BAGUERA®C Cervical Disc Prosthesis

{0} # SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) ## I. GENERAL INFORMATION | Device Generic Name: | Artificial Cervical Disc | | --- | --- | | Device Trade Name: | BAGUERA® C Cervical Disc Prosthesis | | Device Product Code: | MJO | | Applicant's Name and Address: | Spineart USA, Inc. 23332 Mill Creek Drive, Suite 150 Laguna Hills, California 92653 | | Date of Panel Recommendation: | None | | Premarket Approval Application (PMA) Number: | P250042 | | Date of FDA Notice of Approval: | August 10, 2026 | ## II. INDICATIONS FOR USE The BAGUERA® C Cervical Disc Prosthesis is indicated for use in skeletally mature patients for reconstruction of the disc at one or two contiguous levels from C3-C7 following single-level or two-contiguous-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level or two-contiguous-level abnormality localized to the level of the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic resonance imaging (MRI)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Patients receiving the BAGUERA® C Cervical Disc Prosthesis should have failed at least six weeks of non-operative treatment or have the presence of progressive symptoms (e.g., numbness or tingling) prior to implantation. The BAGUERA® C Cervical Disc Prosthesis is implanted via an open anterior approach. ## III. CONTRAINDICATIONS The BAGUERA® C Cervical Disc Prosthesis should not be implanted in patients with the following conditions: PMA 250042: FDA Summary of Safety and Effectiveness Data 1 of 147 {1} - Compromised vertebral bodies at the index level(s) due to previous trauma to the cervical spine or to significant cervical anatomical deformity (e.g., scoliosis) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis); - Facet joint disease or degeneration; - Marked cervical instability on resting lateral or flexion/extension radiographs demonstrated by translation greater than or equal to 3.5mm and/or greater than 11 degrees of angular difference from either adjacent segments; - Active systemic or local infection; - Allergy or sensitivity to the implant materials (titanium, aluminum, vanadium or polyethylene); - Osteoporosis or osteopenia defined as dual energy x-ray absorptiometry (DEXA) scan of the spine with a bone density T-score less than or equal to -1.5. # IV. WARNINGS AND PRECAUTIONS The warnings and precautions can be found in the BAGUERA® C Cervical Disc Prosthesis labeling. # V. DEVICE DESCRIPTION The BAGUERA® C Cervical Disc Prosthesis is an artificial cervical disc that is inserted into the intervertebral disc space at one or two contiguous levels using an anterior approach. It is manufactured from titanium (Ti-6Al-4V alloy per ASTM F136 and ISO 5832-3) endplates and a mobile, Vitamin E blended crosslinked high-density polyethylene (AO-XLPE GUR® 1020E per ASTM F648 and ASTM F2695-12) core. The titanium endplates have a plasma-sprayed titanium coating per ISO 13179-1. The articulating surface of the endplates is coated with a non-permeable, diamond-like carbon (DLC) film, deposited by plasma-activated chemical vapor deposition (PACVD). The device is pictured in Figure V-1 below.   Figure V-1 BAGUERA® C Cervical Disc Prosthesis: assembly (left), and mid-sagittal section (right) PMA 250042: FDA Summary of Safety and Effectiveness Data 2 of 147 {2} The final implant is pre-mounted on a disposable radiolucent fork to allow the device to remain in the assembled configuration during the surgical procedure while enabling fluoroscopic controls of the implant positioning. The BAGUERA® C Cervical Disc Prosthesis product range is based on a homothetic shape designed around the AO-XLPE core, so that the weight-bearing surface withstanding the compressive load is intended to remain constant regardless of the implant size. Note that the AO-XLPE nucleus is the same shape and size for the complete product range. With its hemi-spherical domed shape, the guided nucleus is designed to enable the functional spine unit to have an adaptive center of rotation and is intended to allow 6 degrees of freedom. In addition, the AO-XLPE nucleus and the endplates are designed to achieve 8° lateral bending and flexion/extension, resulting in 16° Range of Motion (ROM). The axial rotation is limited by the anatomical structures and not constrained by the prosthesis. These ranges of motion are intended to permit the patient's anatomy to determine actual range of motion without imposing an artificial limit that may be restrictive to the patient's kinematic profile. The maximum range of motion in vivo will be dictated by the patient's anatomical boundaries or the device limits, whichever is smaller.  Figure V-2 Exploded view of the BAGUERA® C Cervical Disc Prosthesis Superior and inferior endplates are available in three footprints (Small, Medium, Large), three thicknesses resulting in three different heights (5mm, 6mm, 7mm) as outlined in Figure V-3 and Table 1 below.    Figure V-3 BAGUERA® C Cervical Disc Prosthesis height range, where height corresponds to the posterior height of the prosthesis. PMA 250042: FDA Summary of Safety and Effectiveness Data 3 of 147 {3} **Table 1** The BAGUERA® C Cervical Disc Prosthesis Product Range | Height | SMALL: 13x16mm | MEDIUM: 14x17mm | LARGE: 16x18mm | | --- | --- | --- | --- | | 5 mm | BAG-CT 13 05-S | BAG-CT 14 05-S | BAG-CT 16 05-S | | 6 mm | BAG-CT 13 06-S | BAG-CT 14 06-S | BAG-CT 16 06-S | | 7 mm | BAG-CT 13 07-S | BAG-CT 14 07-S | BAG-CT 16 07-S | ## VI. ALTERNATIVE PRACTICES AND PROCEDURES There are several other alternatives for the treatment of intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level or two-contiguous-level abnormality localized to the level(s) of the disc space. These alternative treatments are summarized below: - Nonoperative alternative treatments, which include, but are not limited to, simple neck adjustments, physical therapy, traction, heat, medications, braces, chiropractic care, bed rest, spinal injections, or exercise programs. - Surgical alternatives, which include, but are not limited to: - Surgical decompression alone - Surgical decompression via an anterior approach with fusion using various bone grafting and anterior plating techniques - Surgical decompression using intervertebral cages, with various bone grafting techniques, with or without supplemental anterior plating - Decompression with posterior spinal systems (e.g., rods, hooks, wires) - Another FDA-approved artificial cervical disc Each option has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle. ## VII. MARKETING HISTORY The BAGUERA® C Cervical Disc Prosthesis has been marketed outside of the United States since 2007. It is currently distributed in Spain, Germany, France, Belgium, Portugal, United Kingdom, Ireland, Italy, Austria, Switzerland, Greece, Monaco, Poland, Romania, Slovakia, Russian Federation, China, Korea, Taiwan, Australia, New Zealand, Malaysia, Singapore, Thailand, Vietnam, Mauritius, Mexico, Cayman Islands, Dominican Republic, Panama, Peru, Martinique, Argentina, Brazil, Colombia, Uruguay, Venezuela, Algeria, South Africa, Iraq, Israel, India, Kazakhstan, Kuwait, Saudi Arabia, United Arab Emirates. The BAGUERA® C Cervical Disc Prosthesis has not been withdrawn from any distribution/marketing in any country for safety or effectiveness reasons. PMA 250042: FDA Summary of Safety and Effectiveness Data 4 of 147 {4} # VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH Below is a list of the potential adverse effects (e.g., complications) identified from the BAGUERA® C Cervical Disc Prosthesis clinical study results, approved device labeling for other cervical total disc replacement devices, and published scientific literature including: (1) those associated with any general surgical procedure; (2) those associated with anterior cervical spine surgery; and (3) those associated with a cervical artificial disc device, including the BAGUERA® C Cervical Disc Prosthesis. In addition to the risks listed below, there is also the risk that surgery may not be effective in relieving symptoms or may cause worsening of symptoms. Additional surgery may be required to correct some of the adverse effects. # General Surgery Risks General surgical risks include but are not limited to: infection/abscess/cyst, localized or systemic, blood clots, including pulmonary emboli, Medication and anesthesia reactions, phlebitis, pneumonia, atelectasis, soft tissue damage, septicemia, hemorrhage possibly requiring a blood transfusion, with possible transfusion reaction, myocardial infarction, paralysis, poor tissue healing, cerebrovascular accident (CVA), and death. # Anterior Cervical Surgery Risks Anterior cervical surgical risks include, but are not limited to: infection/abscess/cyst, localized or systemic, injury or damage to the trachea, esophagus, nerves or blood vessels, dysphagia, hoarseness, vocal cord paralysis, paresis, recurrent laryngeal nerve palsy, soft tissue damage, spinal cord damage, dural tear with cerebrospinal fluid leakage, arm weakness or numbness, bowel, bladder or sexual dysfunction, nerve root injury, airway obstruction, epidural hematoma or bleeding, epidural fibrosis, vertebral body fracture, dysesthesia or numbness, paresthesia, unresolved pain, surgical intervention at incorrect level, need for supplemental fixation, spinal instability, and death. # Cervical Artificial Disc Risks Risks specific to cervical artificial discs, including the BAGUERA® C Cervical Disc Prosthesis, include, but are not limited to: infection/abscess/cyst, localized or systemic, allergic reaction to the implant materials, implant failure, device migration, device subsidence, device fatigue or fracture or breakage, device instability, separation of device components, placement difficulties, device malposition, improper device sizing, excessive device height loss, wear debris, disc space collapse, material degradation, excessive facet loading, kyphosis or hyper-extension, loss of flexibility, asymmetric range of motion, vertebral body fracture, spinal cord damage, dural tear with cerebrospinal fluid leakage, soft tissue damage, epidural fibrosis, nerve injury, paralysis or weakness that is temporary or permanent, injury or damage to the trachea, esophagus, or blood vessels, epidural PMA 250042: FDA Summary of Safety and Effectiveness Data 5 of 147 {5} hematoma or bleeding, dysesthesia or numbness, paresthesia, failure to relieve symptoms including unresolved pain, additional surgery due to loss of fixation, infection or injury, spontaneous fusion due to heterotopic ossification, development of bridging bone or osteophytes, periarticular calcification and fusion, development of spinal conditions, including but not limited to spinal stenosis, spondylolisthesis, or retrolisthesis, removal, revision, reoperation or supplemental fixation of the disc, osteolysis, bone loss, or bone resorption, and death. These conditions do not include all potential adverse events (AEs) that may occur but are important considerations in relation to the use of the BAGUERA® C Cervical Disc Prosthesis. For specific AEs that occurred in the single-level and two-contiguous level clinical studies, please see Section X.A.4 and Section X.B.4 respectively. ### IX. SUMMARY OF PRECLINICAL STUDIES A variety of testing was conducted to characterize the performance of the BAGUERA® C Cervical Disc Prosthesis, including: *Laboratory Studies* - Static Axial Compression - Dynamic Axial Compression - Static Compression Shear - Dynamic Compression Shear - Subluxation/ Expulsion - Subsidence - Wear (Mode I Wear) - Third Body Wear (Mode 3 Wear) - Impingement (Mode 4 Wear) - Coating Testing *Additional Studies* - MR Compatibility - Biocompatibility/ Pyrogenicity/ Neurotoxicity - Device Sterilization - Shelf Life and Transit Validation ### A. Laboratory Studies A summary of the conducted laboratory testing is presented in the following table, stratified by the above classifications (Table 2). PMA 250042: FDA Summary of Safety and Effectiveness Data 6 of 147 {6} Table 2 Non-Clinical Study Summary | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Static and Dynamic Strength | | | | | | Static Axial Compression | Verify the performance of the BAGUERA® C under simulated physiologic conditions is sufficient to withstand in vivo static compressive loads. | Five (5) final, finished, sterilized BAGUERA® C devices were aged per ASTM F2003 and tested under static compression at a rate of 25 mm/min until functional failure occurred or a specified load limit of 10 kN was reached. Testing was according to ASTM F2346. | The yield load must be at least 74 N^{1}. | Average yield load: 2180.0 N Static stiffness (for information only): 2,886.8 N/mm. The acceptance criteria were met. | | Dynamic Axial Compression | Verify the performance of the BAGUERA® C under simulated physiologic conditions is sufficient to withstand in vivo dynamic (fatigue) compressive loads. | Three (3) final, finished, sterilized BAGUERA® C devices were aged per ASTM F2003 and tested under dynamic compression in 0.9% saline solution to 10 million cycles using a 2 Hz sinusoidal wave form with R=10. Testing was according to ASTM F2346. | The runout load must exceed 74^{1} N at 10 million cycles. | Three samples were tested to 10 million cycles at 500 N of axial compression. No mechanical or functional failures were observed. The acceptance criteria were met. | | Static Compression – Shear | Verify the performance of the BAGUERA® C under simulated physiologic conditions is sufficient to withstand in vivo static compression - shear loading. | Five (5) final, finished, sterilized BAGUERA® C devices were aged per ASTM F2003 and tested under a static axial load with samples positioned at 45° relative to the loading axis at a rate of 25 mm/min , until functional failure occurred or a specified load limit of 10 kN was reached. Testing was according to ASTM F2346. | The yield load must be at least 20 N^{1}. | Average yield: 1342.8 ± 64.4 N. The acceptance criteria were met. | | Dynamic Compression – Shear | Verify the performance of the BAGUERA® C under simulated physiologic conditions is sufficient to withstand in vivo dynamic compression - shear loading. | Three (3) final, finished, sterilized BAGUERA® C devices were aged per ASTM F2003 and tested under dynamic compression in 0.9% saline solution to 10 million cycles using a 2 Hz sinusoidal wave form with R=10. Testing was according to ASTM F2346. | The runout load must exceed 20 N^{1} at 10 million cycles. | Three samples were tested to 10 million cycles at 300 N of compression shear. No mechanical or functional failures were observed. The acceptance criteria were met. | PMA 250042: FDA Summary of Safety and Effectiveness Data 7 of 147 {7} | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | **Subluxation / Expulsion** | | | | | | Subluxation and Expulsion | Verify the ability of the BAGUERA® C to resist expulsion and subluxation using simulated physiologic conditions. | Ten (10) final, finished, sterilized BAGUERA® C devices were aged per ASTM F2003 and provided for testing: n=5 for subluxation and n=5 for expulsion. Devices were tested at a rate of 6 mm/min in the posterior to anterior direction for a minimum of 3mm of total device displacement under a constant axial load of 150 N. Horizontal load and displacement was collected at a sampling rate of 100 Hz. | The subluxation and expulsion force must be at least 20 N^{1}. | The average subluxation force was 241 ± 13 N, which meets the acceptance criteria. There was also no evidence of mechanical or functional failure of the devices. The average expulsion force was 298 ± 4 N which meets the acceptance criteria. There was also no evidence of mechanical or functional failure of the devices. | | **Subsidence** | | | | | | Subsidence | Verify the ability of the BAGUERA® C to resist subsidence using simulated physiologic conditions. | Five (5) final, finished, sterilized BAGUERA® C devices were aged per ASTM F2003. The devices were axially loaded at a rate of 0.1 mm/s until contact occurred between the superior and inferior foam test blocks. Load, displacement, and signs of mechanical damage to the implant and test blocks were recorded. Testing was conducted per ASTM F2267. | The yield load offset displacement at 1mm must be greater than 74 N^{1}. | The yield load was 1222 ± 95 N and yield displacement was 2.6 mm, and the K_{p} was 1078 ±119 N/mm, which meets the acceptance criteria. | | **Creep and Relaxation** | | | | | PMA 250042: FDA Summary of Safety and Effectiveness Data 8 of 147 {8} | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Creep and Stress Relaxation | To evaluate the creep characteristics of the BAGUERA® C. | Six (6) final, finished, sterilized BAGUERA® C devices were aged per ASTM F2003 and tested to evaluate the extent of creep under a constant load for a duration of over 1000 hours. Testing was in accordance with ASTM D2990-17. Each device was loaded on a custom fixture and subjected to a constant 150 N load, initially applied at 30 N/s. Displacement was recorded for 1, 6, 12, and 30 minutes and at 1, 2, 5, 20, 50, 100, 200, 500, 700, and 1000 hours. | No devices should demonstrate evidence of mechanical or functional failure, and the nucleus of the finished device shall not lose more than 0.20 mm of height after 1,000 hours of testing. | The average displacement under a constant load of 150 N after 1000 hours was 0.11 ± 0.05 mm. No evidence of mechanical or functional failure of the devices was observed. The devices met the acceptance criteria. | | **Wear** | | | | | | Wear, Mode I (Pristine Wear Testing) | Characterize *in vivo* wear properties. | Ten (10) test articles were tested. Four (4) were for load soak and soak controls and six (6) for wear testing. All samples were subjected to 6 weeks of accelerated aging per ASTM F2003 prior to testing. Six (6) devices were subjected to 10 x 10^{6} cycles of loads and motions prescribed for cervical disc prostheses in ASTM 2423 and ISO 18192-1 while submerged in bovine serum solution with a protein concentration of 5g/L. The test profiles used in the testing were: ±7.5° flexion-extension, ±6° lateral bending, ±6° rotation, and 50 – 150 N compressive axial load. A motion profile with a constant frequency of 1.0 Hz was applied to each specimen. | The device will reach 10 MC without mechanical or functional failure. | Average total mass loss: 6.0 ± 1.3 mg Average mass loss rate: 0.6 ± 0.1 mg/MC No devices demonstrated signs of mechanical or functional failure. All acceptance criteria were met. | PMA 250042: FDA Summary of Safety and Effectiveness Data 9 of 147 {9} | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Wear, Mode III (Abrasion) | To characterize in vitro wear properties under third-body abrasive wear conditions | Testing based on ISO 18192-1 and ASTM F2423. Specimens were subjected to combined ±7.5° flexion/extension, ±6° axial rotation, and ±6° lateral bending while submerged in third-body titanium particle slurry bovine serum lubricant. Testing was performed at 1.0 Hz with a 50-150 N applied load. | N/A, for characterization purposes | Mean mass wear rates – - Superior Endplate: 0.3 mg/MC at 1MC, 0.1 mg/MC at 5MC - AO-XLPE Core: 2.8 mg/MC at 1MC, 1.6 mg/MC at 5MC - Inferior Endplate: 0.2 mg/MC at 1MC, 0.1 mg/MC at 5MC. Average scratch height of 1.7μm in the superior endplates and 0.6μm on the inferior endplates. Average penetration of 0.25 ± 0.1 mm for the wear stations and had a penetration measurement range of 0.0 mm to 0.1 mm for the load soak stations after 5.0 MC. No measurable penetration on the articulating surfaces of the superior and inferior endplates following 5.0 MC of testing. Particle analysis shows size distributions and morphology in ranges consistent with other spine/ortho devices. No devices demonstrated signs of fracture or functional failure. | PMA 250042: FDA Summary of Safety and Effectiveness Data 10 of 147 {10} | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Wear, Mode IV (Impingement) | Characterize the impingement properties using simulated physiologic conditions. | Ten (10) test articles were tested. Four (4) were for load soak and soak controls and six (6) for wear testing. All samples were subjected to 6 weeks of accelerated aging per ASTM F2003 prior to testing. Six (6) devices were then subjected to 1 x 10^{6} cycles in a posterior impingement position of combined 150 N axial load, 12-20° flexion and extension and ±4° axial rotation at 1 Hz per ISO 18192-1 and ASTM F3295 while submerged in bovine serum solution with a protein concentration of 5 g/L. | The device will reach 1 MC without mechanical or functional failure. | Average total mass loss: SM: 13.6 mg LG: 7.7 mg Average mass wear rates: SM: 13.2 mg/MC LG: 6 mg/MC No devices demonstrated signs of mechanical or functional failure. | | **Porous Titanium Coating Testing** | | | | | | Coating Shear Fatigue | Evaluate coating in shear fatigue testing. | Fifteen (15) test specimens were tested per ASTM F1160. | No defect after 10^{7} cycles at 10MPa. | None of the test specimens showed any evidence of coating failure. The acceptance criterion was met. | | Coating Static Shear Strength | Evaluate coating in static shear testing. | Thirty (30) test samples were tested per ASTM F1044. | > 20 MPa | Range (min-max) 52.5- 74.6MPa The acceptance criterion was met. | | Coating Static Tensile Strength | Evaluate coating in tensile testing. | Thirty (30) test samples were tested per ASTM F1147. | > 22 MPa | Range (min-max): 35.6-72.3MPa The acceptance criterion was met. | | Coating Abrasion | Coating taber abrasion testing. | Fifteen (15) test specimens were tested per ASTM F1978. | < 65 mg after 100 cycles. | Average mass loss after 100 cycles was less than 65 mg after 100 cycles. The acceptance criterion was met. | | Coating Characterization | Characterize coating morphology. | Visual inspection, n = 90. | Homogeneity | Homogeneous coating present. The acceptance criterion was met. | PMA 250042: FDA Summary of Safety and Effectiveness Data 11 of 147 {11} | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | | Coating thickness per ASTM 1854, n = 90. | 150 ± 30 μm (120-180μm) | Range (min-max): 132.3-172.9 μm The acceptance criterion was met. | | | | Coating porosity per ASTM 1854, n = 90. | 30 ± 10% (20-40%) | Range (min-max): 22.7- 36.1% The acceptance criterion was met. | | | | Coating roughness (Rt) based on ISO 21920, n = 90. | 156 – 354 μm | Range (min-max): 237.3- 327.0 μm The acceptance criterion was met. | | **DLC Coating Testing** | | | | | | Coating Shear Fatigue | Evaluate coating in shear fatigue testing. | Fifteen (15) test specimens were tested per ASTM F1160. | No defect after 10^{7} cycles at 10MPa. | None of the test specimens showed any evidence of coating failure. The acceptance criterion was met. | | Coating Static Shear Strength | Evaluate coating in static shear testing. | Thirty (30) test samples were tested per ASTM F1044. | > 20 MPa | Range (min-max): 39.8-54.7MPa The acceptance criterion was met. | | Coating Static Tensile Strength | Evaluate coating in tensile testing. | Thirty (30) test samples were tested per ASTM F1147. | > 22 MPa | Range (min-max): 40.2-65.4MPa The acceptance criterion was met. | | DLC Coating Characterization | Characterize coating morphology. | Visual inspection, n = 102 | Homogeneous coating^{2} | Homogeneous. Acceptance criterion was met. | | | | Coating thickness per ASTM 1854 (n=102) | 2 – 3 μm | Range (min-max): 2.0-2.5μm | | | | Coating adhesion, n = 102 (PQ) per ISO 26443 | Class 0 – Class 1 (Load: 100kg) | All samples met the acceptance criterion. | | | | Coating roughness (Ra), n = 102 (PQ) per ISO 21920 | ≤ 0.1 μm | All samples met the acceptance criterion. | PMA 250042: FDA Summary of Safety and Effectiveness Data 12 of 147 {12} | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Nucleus Material Comparative Assessment | | | | | | Material Characterization | Characterize two (UHMWPE and AO-XLPE) polyethylene materials. | UHMWPE and AO-XLPE nucleus materials were subjected to all non-clinical laboratory testing. Additionally, AO-XLPE nuclei were included in the wear particle generation for the rabbit particulate study. | Minimal to no impact on BAGUERA® C: • Surgical technique • Design, range, and kinematics • Cleaning, packaging, sterilization • Biocompatibility • Manufacturing • Clinical safety / performance | The AO-XLPE material demonstrated minimal to no impact on the BAGUERA® C. | 1. White AA, Panjabi MM. Clinical Biomechanics of the Spine. 2nd ed., J.B. Lippincott Company, 1990. 2. Under magnification x2.3, no shock, lack of coating, adhesion defect, electric arc, coloration > 300 μm and no more than 3 defects < 300μm in the functional area of the parts. ### B. Animal Studies - Rabbit A particulate injection study was conducted in rabbit models to evaluate potential toxicity associated with debris and particulate obtained from AO-XLPE, Ti6Al4V and DLC particulates when placed in direct contact with the spinal column via epidural injection. Summary data for this study is provided in the following table. Table 3 Animal Study Summary | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Injection Study | To evaluate the local effects of AO-XLPE, Ti6Al4V and DLC wear debris | Rabbits were injected in the epidural space (i.e. target placement on nerve root and in proximity to dura) with a negative control (NC) solution (sterile saline), a control (SPC) solution (AO-XLPE particulate) or a test solution (effective dose of ~4 mg of the dried wear debris particulates suspended in ~400 μL of sterile saline providing an approximate dose of 1.1 mg/kg injected into n=54 total rabbits) representative of wear debris. Rabbits were terminated at 4, 13 and 26 weeks. Local and distant tissues were harvested and examined for gross pathology (if present) and the tissue was analyzed histologically. | The test was for characterization purposes and acceptance criteria were not established. | Characterization of response to wear particles near the spine. There were no adverse clinical or macroscopic observations that are related to test, SPC, or NC article applications in 4-, 13-, and 26-week animals. There was no macroscopic or microscopic evidence of systemic toxicity in the liver and spleen tissues following intra-epidural injection of the TA, or the SPC at 4-, 13- or 26-weeks post-injection. A small amount of intracytoplasmic black | PMA 250042: FDA Summary of Safety and Effectiveness Data 13 of 147 {13} | Test Name | Purpose | Test Method | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | | | | pigment present within macrophages (interpreted to be the DLC coating) were found in the epidural space of almost all test animals at all three time points. The TA elicited minimal or no reaction when compared to the SPC and NC articles. | ### C. Additional Studies #### a) Magnetic Resonance (MR) Imaging The safety and compatibility of the BAGUERA® C Cervical Disc Prosthesis in the Magnetic Resonance (MR) environment was evaluated. Specifically, it was tested for magnetic field interactions, heating, and artifacts associated with clinically relevant magnetic resonance imaging. The magnetic field interaction evaluations consisted of displacement and torque assessments. For the assessment of displacement, an induced displacement force test was performed in accordance with ASTM F2052. The evaluation of magnetic torque was performed in accordance with ASTM F2213. The BAGUERA® C Cervical Disc Prosthesis was tested for MRI-related heating in accordance with ASTM F2182. MR imaging artifacts were assessed in accordance with ASTM F2119. The results of the assessments demonstrated that the BAGUERA® C Cervical Disc Prosthesis is MR Conditional. A patient with the BAGUERA® C Cervical Disc Prosthesis can be scanned safely in an MR system under the following conditions: - Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T). - Maximum spatial gradient field less than or equal to 4,000 Gauss/cm (40 T/m). - Operating mode, allowable whole-body SAR (SARwb), and/or allowable B1+RMS varies by landmark position as detailed below: - 1.5 T: Normal Operating Mode - 3 T: Normal Operating Mode from navel to bottom of foot; SARWB ≤ 0.4 W/kg or B1+RMS ≤ 2 μT from bottom of mandible to navel. PMA 250042: FDA Summary of Safety and Effectiveness Data 14 of 147 {14} - Scan Duration: under the exposure conditions outlined in Operating Mode section above, up to 1 hour of continuous scanning is permissible without a cooling period. - Scan Region: under the exposure conditions outlined in Operating Mode section above, any landmark is acceptable. In non-clinical testing per ASTM F2119, the image artifact caused by the BAGUERA® C Cervical Disc Prosthesis extends approximately 2.6 cm for a Gradient Echo scan at 3T. Some manipulation of scan parameters may be needed to compensate for the artifact. # b) Biocompatibility The BAGUERA® C Cervical Disc Prosthesis is manufactured from Titanium alloy, diamond-like carbon, vitamin E blended crosslinked high-density polyethylene, and commercially pure titanium plasma spray (TPS). All implant materials have a long history of successful orthopedic and cardiovascular clinical use and well-established biocompatibility. Biocompatibility testing was performed on the BAGUERA® C Cervical Disc Prosthesis in its final sterilized state in accordance with ISO 10993-1, ISO 10993-12, ISO 10993-17, and ISO 10993-18, for the level of contact duration of a permanent implant contacting tissue and bone. The battery of biocompatibility tests conducted included: Cytotoxicity (ISO 10993-5), Pyrogenicity (ISO 10993-11), Bacterial Endotoxin Evaluation (ANSI/AAMI ST72, USP<85>, USP<161>), and Biological Risk Assessment (ISO 10993-1, -12, -17, -18). All test results met the acceptance criteria demonstrating biocompatibility in line with the requirements of ISO 10993-1. # c) Sterilization Validation Full sterilization validation has been conducted for the BAGUERA® C Cervical Artificial Disc implants per ISO 11137. Full sterilization validation has been conducted for the BAGUERA® C Cervical Artificial Disc Instruments per ANSI/AAMI ST79, AAMI TIR12, and ISO 17665-1. # d) Shelf Life and Transit Validation Shelf life and transit validation studies, including assessments of packaging seal integrity and real-time aging stability testing, were conducted to demonstrate that the device packaging can maintain a sterile barrier over an 8-year shelf life. PMA 250042: FDA Summary of Safety and Effectiveness Data 15 of 147 {15} # X. SUMMARY OF PRIMARY CLINICAL STUDIES The applicant performed two clinical studies to establish a reasonable assurance of safety and effectiveness of replacement of the degenerated disc with the BAGUERA® C Cervical Disc Prosthesis following single-level and two-contiguous level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level or two-contiguous level abnormality localized to the level(s) of the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic resonance imaging (MRI)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The studies were performed in the United States under IDE G200182 (single-level) and IDE G200239 (two-contiguous levels). The IDE studies consisted of one-level and two-level treatment populations each enrolled in two separate concurrent clinical studies. A summary of the one-level clinical study is provided below in section A, a summary of the two-level clinical study is provided below in section B. Data from these clinical studies were the basis for the PMA approval decision. Summaries of the clinical studies are presented below. PMA 250042: FDA Summary of Safety and Effectiveness Data 16 of 147 {16} ### A. Single-Level Cervical Disc Replacement #### 1. Pivotal Study Design Subjects in the pivotal clinical trial were treated between February 2021 and March 2024. The prospective, multi-center, randomized, controlled clinical study was conducted under IDE G200182 to compare the BAGUERA \( ^{®} \) C Cervical Disc Prosthesis (investigational device) to the Mobi-C \( ^{®} \) Cervical Disc (control device), a PMA approved artificial cervical disc. The database for this PMA reflects data collected on a total of 309 subjects that signed the informed consent and were randomized in the study. Of the 309 subjects, 24 of these subjects remained blinded, and ultimately were not treated, while 285 of these subjects (N=189 BAGUERA \( ^{®} \) C; and N=96 Mobi-C) had an incision time recorded and were enrolled in the study. Subjects were treated at 25 US sites. Subjects were randomized in a 2:1 ratio to the single level BAGUERA \( ^{®} \) C device (investigational group) or to the single-level Mobi-C device (control group), respectively. A statistical plan was designed to test non-inferiority between the two groups. ##### a) Clinical Inclusion and Exclusion Criteria To be eligible for the IDE study, subjects had to meet all of the inclusion criteria and none of the exclusion criteria in Table 4: Table 4 Study Inclusion and Exclusion Criteria for IDE G200182 (single-level) | Study Inclusion Criteria | Study Exclusion Criteria | | --- | --- | | In order to be eligible to participate in this study, subjects must meet all of the following criteria:1. Male or female; skeletally mature; age 22-69 years, inclusive.2. Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesia or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:a. Neck and/or arm pain (at least 40 mm on the 100 mm visual analogue scale [VAS] scale).b. Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.c. Abnormal sensation including hyperesthesia or hypoesthesia; and/ord. Abnormal reflexes.3. Symptomatic cervical disc disease (SCDD) at one level from C3 to C7. | Subjects who meet any of the following criteria will be excluded from participating in this study:1. Have an active systemic infection or infection at the operative site.2. Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.3. More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic “spontaneous” fusions.4. Previous trauma to the C3 to C7 levels resulting in significant bony or discoligamentous cervical spine injury.5. Had any prior spine surgery at the operative level.6. Had a prior cervical fusion or artificial disc procedure at any cervical level. | PMA 250042: FDA Summary of Safety and Effectiveness Data 17 of 147 {17} | Study Inclusion Criteria | Study Exclusion Criteria | | --- | --- | | 4. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following: a. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc. b. Degenerative spondylosis on CT or MRI. c. Disc herniation on CT or MRI. 5. NDI Score of ≥ 30% (raw score of ≥15/50). 6. Preoperative neck or arm pain ≥ 40 (out of 100) on Preoperative Neck and Arm Pain Questionnaire. 7. Unresponsive to non-operative, conservative treatment (including but not necessarily limited to: rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: a. Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or b. Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment. 8. Appropriate for treatment using an anterior surgical approach, including having no prior surgery at the operative level and no prior cervical fusion or cervical artificial disc procedure at any level. 9. Medically cleared for surgery. 10. Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol. 11. Written informed consent provided by subject | 7. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy. 8. Disc height less than 3 mm as measured from the center of the disc in a neutral position. 9. Radiographic confirmation of severe facet joint degeneration or confirmed clinical evidence that facet joint degeneration is a major contributor to the subject's pain. 10. Have osteoporosis or osteopenia, defined as a DEXA bone density measured T-score of ≤ -1.5 (i.e. -1.6, -1.7, etc.). A DEXA performed within 24 months of the surgery date may be used to determine eligibility. For subjects without a DEXA within 24 months of the surgery date a score of ≥ 6 on either the SCORE or MORES requires a DEXA to determine eligibility. Note: The SCORE (Simple Calculated Osteoporosis Risk Estimation) form should be administered if the subject is female. The MORES (Male Osteoporosis Risk Estimation Score) form should be administered if the subject is male. 11. Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above. 12. Severe diabetes mellitus requiring daily insulin management. 13. Have an active malignancy that includes a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject was treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years. 14. Symptomatic SCDD or significant cervical spondylosis at more than one level. 15. Spondylolysis. 16. Marked cervical instability on resting lateral or flexion-extension radiographs demonstrated by: a. Translation ≥ 3.5 mm, and/or b. Greater than 11° angular difference to that of either adjacent level. 17. Known allergy to Titanium, Vanadium, Aluminum, Cobalt, Chromium, Molybdenum or Polyethylene. | PMA 250042: FDA Summary of Safety and Effectiveness Data 18 of 147 {18} | Study Inclusion Criteria | Study Exclusion Criteria | | --- | --- | | | 18. Segmental angulation of greater than 11° at treatment or adjacent levels. 19. Pregnant at time of enrollment, or with plans to become pregnant within the next three years. 20. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system. 21. Congenital bony and/or spinal cord abnormalities that affect spinal stability. 22. Have diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders, confirmed fibromyalgia, etc.). 23. Concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as: a. Daily, chronic use of oral steroids of 5 mg/day or greater. b. Daily, chronic use of inhaled corticosteroids (at least twice per day). c. Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40mg within one month of the study procedure. 24. Have current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention. 25. Severe Obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI) > 40). 26. Use of any investigational drug or other investigational medical device within the last 30 days prior to surgery. 27. Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents). High dose steroid use is defined as part of Exclusion Criterion #23. 28. Currently pursuing litigation (defined as litigation that will likely influence the patient's ability or willingness to accurately report their treatment outcomes) related to the neck or cervical spine injury. 29. Current history of heavy nicotine use (e.g. more than one pack of cigarettes per day). | PMA 250042: FDA Summary of Safety and Effectiveness Data 19 of 147 {19} | Study Inclusion Criteria | Study Exclusion Criteria | | --- | --- | | | 30. Circumstances that may interfere with completion of follow-up examinations, including location of residence. 31. Belong to a vulnerable population (e.g., prisoner, ward of the court or developmentally disabled). 32. Currently experiencing an acute or chronic episode of confirmed specific mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin. 33. Have an uncontrolled seizure disorder. 34. Received cervical spine epidural steroids within 14 days prior to surgery. | # b) Control Control subjects were prospectively enrolled and randomized to treatment with the Mobi-C® Cervical Disc (N=96), a PMA-approved artificial cervical disc. The Mobi-C Cervical Disc was implanted according to its surgical technique guide. # c) Follow-up Schedule All subjects were evaluated pre-operatively, at treatment/discharge (prior to the subject being discharged from the hospital) and post-operatively at 6 weeks (±2 weeks), 3 months (±2 weeks), 6 months (±1 month), 1 year (±2 months), 2 years (±2 months), and annually thereafter (±2 months). The following parameters (Table 5) were measured throughout the study: PMA 250042: FDA Summary of Safety and Effectiveness Data 20 of 147 {20} Table 5 BAGUERA® C Cervical Disc Prosthesis IDE G200182 Study Assessment Schedule | Procedures | Pre-op | Surgery | 6 Weeks | 3 Months | 6 Months | 12 Months | 24 Months | Annual to 84 Months | Unscheduled | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | ± 2 wks | ± 2 wks | ± 4 wks | ± 8 wks | ± 8 wks | ± 8 wks | | | Informed consent | X | - | - | - | - | - | - | - | - | | Demographics | X | - | - | - | - | - | - | - | - | | Medical History | X | - | X | X | X | X | X | X | X | | Work Status | X | - | X | X | X | X | X | X | - | | Incl/Excl criteria | X | - | - | - | - | - | - | - | - | | Randomization | X | - | - | - | - | - | - | - | - | | Pregnancy Assessment | - | X | - | - | - | - | - | - | - | | MRI or CAT scan | X | - | - | - | - | - | - | - | - | | DEXA scan | X | - | - | - | - | - | - | - | - | | AP Lat X-rays | X | X | X | X | X | X | X | X | - | | Flex-Ext X-rays | X | - | X | X | X | X | X | X | - | | Presenting Symptoms | X | - | X | X | X | X | X | X | - | | Neuro Exam | X | X | X | X | X | X | X | X | X | | Nurick Classification | X | - | - | - | - | - | - | - | - | | Odom's Classification | - | - | - | - | - | - | X | X | - | | NDI | X | - | X | X | X | X | X | X | X | | Neck VAS | X | - | X | X | X | X | X | X | X | | Left/Right Arm VAS | X | - | X | X | X | X | X | X | X | | SF-12v2 | X | - | - | - | X | X | X | X | - | | Patient Satisfaction | - | - | X | X | X | X | X | X | - | | Dysphagia Index | X | - | X | X | X | X | X | X | - | | Medications | X | X | X | X | X | X | X | X | X | | Adverse Events | - | X | X | X | X | X | X | X | X | # d) Clinical Endpoints The safety of the BAGUERA® C Cervical Disc Prosthesis was assessed by comparison to the Mobi-C control group with respect to the nature and frequency of adverse events (overall and in terms of severity, seriousness and relationship to the implant and/or surgical procedure), subsequent index level surgical procedures and maintenance or improvement in neurological status. The effectiveness of the BAGUERA® C Cervical Disc Prosthesis was assessed using a composite endpoint, as described below. Effectiveness was evaluated by assessing improvement in the Neck Disability Index (NDI), neck and arm PMA 250042: FDA Summary of Safety and Effectiveness Data 21 of 147 {21} pain Visual Analogue Scale (VAS) questionnaires, the Dysphagia Handicap Index (DHI), Odom's Criteria, health-related quality of life using the short-form questionnaire (SF-12v2), and patient satisfaction of the BAGUERA® C Cervical Disc Prosthesis treatment compared to the Mobi-C® Cervical Disc treatment. The same criteria were used to measure success in both groups. ## Primary Endpoint The study hypothesis for the BAGUERA® C Cervical Disc Prosthesis IDE G200182 Study was that the Month 24 (i.e., 24 months post-operatively) composite clinical success (CCS) rate of the single-level BAGUERA® C Cervical Disc Prosthesis would be no worse than conventional single-level MOBI-C® Cervical Disc when success is evaluated at Month 24 in patients with intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized at a single level from C3 to C7 that is unresponsive to conservative management or have presence of progressive signs or symptoms of nerve root/spinal cord compression. Individual CCS for both the investigational and control groups was defined as: 1. Improvement in pain and function, as measured through the Neck Disability Index (NDI), of at least 15 percentage points (out of 100%) from pre-operative; 2. Maintenance or improvement in neurological status at 24 months compared to baseline (as determined by the CEC) 3. No secondary surgical intervention defined as revision, removal, reoperation, or supplemental fixation at the index level 4. No serious adverse event(s) confirmed as device or procedure related (as determined by the CEC). Subjects who required device removal (explantation) were withdrawn from the study and were considered a treatment failure. In addition, subjects who required a secondary surgical intervention (SSI) at the index level were considered a treatment failure. Subject success was evaluated using the primary composite endpoint above at Month 24. Study success was evaluated for the Month 24 Composite Clinical Success (CCS) using the following pre-specified hypotheses pertaining to clinical non-inferiority: H₀: πₜ - π꜀ ≤ -0.125 (the CCS rate of investigational device was clinically inferior to control) Hₐ: πₜ - π꜀ > -0.125 (the CCS rate of investigational device was not clinically inferior to control) PMA 250042: FDA Summary of Safety and Effectiveness Data 22 of 147 {22} where πT and πC are the probabilities of achieving Month 24 CCS of the investigational and control devices, respectively. In all circumstances, non-inferiority hypotheses were based on the a priori selected non-inferiority margin, δ = 0.125. The claim of non-inferiority was pre-specified to be accepted if the posterior probability of non-inferiority, is greater than or equal to 0.95. That is, if, Pr(πT - πC > -0.125 | Trial Results) ≥ 0.95. This posterior probability is calculated using Beta(1, 1) non-informative priors for both the investigational and control arms. A Bayesian posterior probability threshold of 0.95 controls type 1 error to 0.05 and supplies statistical power in excess of 80%. Per the FDA Guidance for the Preparation of IDEs for Spinal Systems (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-preparation-ides-spinal-systems-guidance-industry-andor-fda-staff), the following definitions apply: - Reoperation – Any surgical procedure at the index level that does not involve modification, addition or removal of any components of the device in the postoperative or follow-up period. - Revision – Any procedure in the postoperative or follow-up period that adjusts, modifies, or removes part of the original implant configuration with or without replacement of a component – may include adjusting the position of the original configuration in the postoperative or follow-up period. - Removal – A procedure where the entire device is removed with or without replacement of the device in the postoperative or follow-up period. - Supplemental fixation – A procedure in which additional instrumentation not under study is implanted (e.g. supplemental placement of a rod/screw system). ## Secondary Endpoints Secondary endpoints, measured in both treatment groups, included: - Time to recovery (time to first 15 percentage points – out of 100 NDI – improvement) - Left and right arm pain 100mm Visual Analogue Scale (VAS) (an improvement in pain of at least 20mm on the VAS is considered clinically significant) - Neck pain 100mm Visual Analogue Scale (VAS) (an improvement in pain of at least 20mm on the VAS is considered clinically significant) PMA 250042: FDA Summary of Safety and Effectiveness Data 23 of 147 {23} · Dysphagia Handicap Index (24 months compared to baseline) · Health Related Quality of Life (SF-12v2) Physical Component Summary (PCS) · Patient Satisfaction · Odom's Criteria to measure surgical success (determined by the treating physician) # **Other Clinical Measures:** Other clinical measures, evaluated in both treatment groups, included: · Operative time · Estimated blood loss · Length of hospital stay · Work status # **Radiographic Assessments:** Radiographic assessments (performed by an independent imaging core lab), evaluated in both treatment groups, included: · Quantitative Assessment included: ○ Angular Motion ○ Translational Motion ○ Anterior/Posterior/Average Disc Height and Change in Disc Height ○ Disc Angle and Change in Disc Angle · Qualitative Assessment included: ○ Heterotopic Ossification (including bridging bone) ○ Device Condition ○ Device Migration ○ Device Subsidence ○ Superior Interface Radiolucency ○ Inferior Interface Radiolucency ○ Bone-Implant Interface Motion ○ Adjacent Level Disc Degeneration ○ Additional Radiographic Observations # e) Clinical Events Committee A Clinical Events Committee (CEC) was utilized for the BAGUERA® C Cervical Artificial Disc IDE study to mitigate reporting bias of safety-related events. The CEC was comprised of three (3) independent spine surgeons, and a CEC charter was used to define the role of the CEC. The committee was responsible for adjudication of AE (i.e., relationship to device/procedure, seriousness, determination of unanticipated adverse device effects), secondary PMA 250042: FDA Summary of Safety and Effectiveness Data 24 of 147 {24} surgical intervention (SSI) (i.e., classification of revision, removal, reoperation or supplemental fixation), protocol deviations (i.e., classification as Major or Minor), and neurological success criterion (classification of neurologic status at Month 24 as compared to baseline). ### 2. Accountability of PMA Cohort At the time of the May 13, 2026 database lock, a total of 309 subjects signed the informed consent form and were randomized (Intent-to-Treat Analysis Set): - A total of 24 subjects were randomized, remained blinded, and ultimately not treated. o 6 of the 24 subjects did not meet the eligibility criteria defined in Protocol prior to treatment. ○ 7 of the 24 subjects withdrew their consent to participate in the study. ○ 7 of the 24 subjects were withdrawn by the investigator prior to scheduling surgery o 4 of the 24 subjects were lost to contact by the study site and surgery could not be scheduled The resulting 285 available randomized subjects, with an operation date at the time of the database lock (189 BAGUERA \( ^{®} \) C subjects and 96 Mobi-C control subjects) were assessed as part of the modified Intent-to-Treat (mITT) Analysis Set. All subjects treated received the treatment assigned by randomization; therefore, the As-Treated (AT) Analysis Set and Per Protocol (PP) Analysis Set are identical, 189 BAGUERA \( ^{®} \) C subjects, and 96 Mobi-C subjects. See Table 6 and Figure 4 below. Table 6 Accounting Information – G200182 study (single-level) | | BAGUERA® C | Mobi-C | | --- | --- | --- | | Randomized (Intention-To-Treat, ITT, population) | 206 | 103 | | Subjects randomized but not treated | 17 | 7 | | Modified Intention-to-Treat (mITT) Population | 189 | 96 | | As Treated (AT) Population | 189 | 96 | | Per Protocol (PP) Population | 189 | 96 | | Subjects with known primary outcome (CCS) among mITT population | 181 | 85 | | Subjects with missing CCS outcome among mITT population: | 8 | 11 | | - Not yet overdue (between day 730 and 790): | 0 | 1 | | - Missing for other reason: | | | | ○ Lost to Follow-up: | 5 | 5 | | ○ Death: | 1 | 0 | | ○ Missed 24 Month Visit | 2 | 5 | PMA 250042: FDA Summary of Safety and Effectiveness Data 25 of 147 {25} This submission includes data up to the database lock that occurred on May 13, 2026. The Month 24 CCS endpoint within the mITT/PP Analysis Set is based on 99.6% (284/285) of all subjects expected due. Within the mITT Analysis Set, 100% (189/189) of BAGUERA® C subjects, and 99% (95/96) of Mobi-C subjects are theoretically due (Day 730); within this same analysis set, 96% (181/189) of BAGUERA® C subjects, and 89% (85/96) of Mobi-C subjects have a known primary outcome. The subject accountability summary through the Month 24 timepoint is presented in Table 7 for the mITT Analysis Set. The accounting table is stratified by treatment arm with the overall BAGUERA® C group subjects referred to hereafter as the investigational group (“I”), and Control group (“C”) for subjects that have completed follow up through Month 24. ---PMA 250042: FDA Summary of Safety and Effectiveness Data 26 of 147 {26}  Figure 4 IDE G200182 (single-level) study. Subject Accountability Tree PMA 250042: FDA Summary of Safety and Effectiveness Data 27 of 147 {27} **Table 7** G200182 – Subject Accounting Summary Through Month 24 (Day 730). mITT Analysis Set | | Pre-Op | | Treatment | | Week 06 | | Month 03 | | Month 06 | | Month 12 | | Month 24 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | I | C | I | C | I | C | I | C | I | C | I | C | I | C | | **Accounting** | | | | | | | | | | | | | | | | (1) Theoretical follow-up | 189 | 96 | 189 | 96 | 189 | 96 | 189 | 96 | 189 | 96 | 189 | 96 | 189 | 96 | | (2) Cumulative Death | | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | | (3) Cumulative SSI Failures | | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 3 | 7 | 3 | | (4) Not Yet Overdue | | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | | (5) Deaths + SSI failures among theoretically due | | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 3 | 8 | 3 | | (6) Expected Due [(6) =(1)-(4)-(5)] | | | | | 189 | 96 | 189 | 96 | 189 | 96 | 184 | 93 | 181 | 92 | | (7) SSI failures among theoretically due | | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 3 | 7 | 3 | | (8) Expected due + SSI failures among theoretically due [(8)=(6)+(7)] | | | | | 189 | 96 | 189 | 96 | 189 | 96 | 188 | 96 | 188 | 95 | | **All Evaluated Accounting (Actual^{B}) Among Expected Due Procedures** | | | | | | | | | | | | | | | | (9) Procedures with any clinical data in interval† | 189 | 96 | | | 189 | 95 | 184 | 93 | 187 | 94 | 179 | 90 | 174 | 82 | | (10) Visit Compliance (%) | | | | | 100% | 99% | 97% | 97% | 99% | 98% | 97% | 97% | 96% | 89% | | (11) Change in NDI | | | | | | | 184 | 93 | 187 | 94 | 179 | 89 | 174 | 82 | | (12) Composite Clinical Success (CCS) | | | | | | | | | | | | | 174 | 82 | | (13) Actual^{B} % Follow-up for CCS | | | | | | | | | | | | | 96% | 89% | | **Within Window Accounting (Actual^{A}) Among Expected Due Procedures** | | | | | | | | | | | | | | | | (14) Procedures with any clinical data in interval† | 189 | 96 | | | 128 | 67 | 160 | 81 | 135 | 62 | 174 | 85 | 160 | 77 | | (15) Visit Compliance (%) | | | | | 68% | 70% | 85% | 84% | 71% | 65% | 95% | 91% | 88% | 84% | | (16) Change in NDI | | | | | | | 160 | 81 | 135 | 62 | 174 | 84 | 160 | 77 | | (17) Composite Clinical Success (CCS) | | | | | | | | | | | | | 160 | 77 | | (18) Actual^{A} % Follow-up for CCS | | | | | | | | | | | | | 88% | 84% | | **Composite Clinical Success** | | | | | | | | | | | | | | | | (19) Composite Clinical Success (CCS) | | | | | | | | | | | | | 181 | 85 | | (20) Actual^{A} % Follow-up for CCS | | | | | | | | | | | | | 96% | 89% | | †NDI value at baseline, change in NDI at follow-up visits. Source: Tables Follow-up Compliance 1L.sas; Analyzed: 19JUN2026 | | | | | | | | | | | | | | | The following definitions apply to Table 7 above: PMA 250042: FDA Summary of Safety and Effectiveness Data 28 of 147 {28} [1] **Theoretical follow-up:** The theoretical follow-up is the number of subjects treated that would have been examined if all subjects returned on the exact anniversary of their respective initial treatment dates. The theoretical follow-up is determined by selecting a date of database closure (i.e., the date the database was closed to the addition of information). The theoretical row is the treated subjects less those not yet due for a follow-up visit. The date of database closure for the analysis will be listed at the top of the table. [2] **Cumulative Deaths:** Cumulative deaths up to the date of the exact anniversary defining the current interval. Deaths occurring after the exact anniversary are recorded in the next interval. Although the cumulative numbers of deaths are recorded on this row, only deaths among subjects that are theoretically due for that interval are subtracted from theoretically due to determine the number expected due for clinical index evaluation. [3] **Cumulative Secondary Surgical Intervention (SSI) Failures:** Cumulative SSI failures up to the date of the exact anniversary defining the current interval. SSI failures occurring after the exact anniversary are recorded in the next interval. Although the cumulative numbers of SSI failures are recorded on this row, only additional events among subjects that are theoretically due for that interval are subtracted from theoretically due to determine the number expected due for clinical index evaluation. [4] **Not Yet Overdue:** Includes subjects whose treatment anniversary has occurred; however, clinical data has not yet been collected (e.g., NDI is currently unavailable), but the patient is still in the protocol-specified follow-up window. Such subjects may yet be observed, and so follow-up compliance estimates account for this by removing such subjects from the denominator as well as from the numerator when determining compliance ratios. [5] **Deaths + Cumulative Secondary Surgical Intervention Failures among theoretically due:** This row records the sum of deaths and Secondary Surgical Interventions among those theoretically due for follow-up according to the exact anniversary of the scheduled follow-up visit. [6] **Expected due for clinic visit:** This row is the number of subjects expected for a given time interval. These include the theoretical number of subjects who are due to be evaluated, less the number of subjects who died, and less the number of subjects in the "Not yet overdue" category. Expected = Theoretical - [Deaths + SSI Failures+ Not yet overdue] where the counts of the numbers of deaths and Not Yet Overdue are determined from among the theoretically due subjects. This row serves as the denominator for evaluation % follow-up for clinical indices (e.g., NDI). The Expected row includes subjects lost to follow-up, and major protocol violations are included in the expected group for all time points. [7] **SSI Failures among theoretically due:** This row records the Secondary Surgical Interventions among those theoretically due for follow-up according to the exact anniversary of the scheduled follow-up visit. [8] **Expected due + SSI Failures among theoretical due:** Expected due plus theoretical due Failures is computed by adding expected due in row (6) to the number of cumulative Failures among theoretically due devices in row (7). This row serves as the denominator for composite clinical success (CCS) outcomes since CCS status is known for subjects with a Failure as defined in row (3). [9] **Procedures with any clinical data in the interval:** The number of subjects with any clinical data for all evaluated subjects among expected due procedures. If any case report is recorded with a date, the subject will be considered to have contributed any data in the interval. [10] **Visit Compliance among expected (%):** The percentage of subjects compliant with the specified visit scheduled for all evaluated subjects among expected due procedures. This rate will not necessarily equal the primary observed endpoint data. [11] **Change in NDI:** The number of subjects reporting a change in NDI for all evaluated subjects among expected due procedures. Subjects without baseline NDI can never contribute to this row. [12] **Composite Clinical Success (CCS):** These rows indicate the number of subjects with enough data available for evaluation of clinical composite success for all evaluated subjects among expected due procedures (12) [13] **Actual B follow-up for CCS(%):** The number of subjects with Month 24 CCS data among all subjects enrolled in the study. This will be the primary measure of study compliance. [14] **Procedures with any clinical data in the interval:** Repeats (9) restricted to evaluations performed within the interval. [15] **Visit Compliance among expected (%):** Repeats (10) restricted to evaluations performed within the interval. [16] **Change in NDI:** Repeats (11) restricted to evaluations performed within the interval. [17] **Composite Clinical Success (CCS):** These rows indicate the number of subjects with enough data available for evaluation of clinical composite success for all subjects that are within window among expected due procedures (21). PMA 250042: FDA Summary of Safety and Effectiveness Data 29 of 147 {29} [18] Actual ^ follow-up for CCS (%): Repeats (13) restricted to evaluations performed within the interval. [19] Composite Clinical Success: The number of subjects with primary endpoint data (Month 24 CCS), including terminal failures from SSIs, amongst all subjects enrolled in the study. This is the primary analysis set. [20] Actual ^ Follow-up for CCS: The proportion of subjects with primary endpoint data, including terminal failures from SSIs, amongst all subjects enrolled in the study. ### 3. Study Population Demographics and Baseline Parameters The tables below provide a summary of pre-operative and demographic variables for subjects treated in the study for both the investigational and control groups in the mITT Analysis Set. Variables summarized include age, BMI, height, and weight stratified by gender as well as race and ethnicity. Further, the demographics of the study population are typical for a cervical total disc replacement study performed in the United States. The proportions enrolled are consistent with the sex, age, racial and ethnicity of other cervical total disc replacement studies conducted to support a PMA with single-level indications in the US. PMA 250042: FDA Summary of Safety and Effectiveness Data 30 of 147 {30} Table 8 Baseline Demographic Continuous Variables. (mITT Analysis Set, N=285) | | BAGUERA® C | | | | | | Mobi-C | | | | | | Group Difference* | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | N | Mean | SD | Med | Min | Max | N | Mean | SD | Med | Min | Max | Δ | LB | UB | p | | All | | | | | | | | | | | | | | | | | | Age (years) | 189 | 44.7 | 8.6 | 44.0 | 22.0 | 67.0 | 96 | 46.4 | 9.2 | 45.0 | 29.0 | 69.0 | -1.7 | -3.9 | 0.5 | 0.057 | | BMI (kg/m2) | 189 | 28.3 | 5.1 | 27.4 | 17.1 | 39.1 | 96 | 29.0 | 5.3 | 28.4 | 18.8 | 39.8 | -0.7 | -1.9 | 0.6 | 0.178 | | Height (in) | 189 | 68.0 | 3.9 | 69.0 | 56.0 | 77.0 | 96 | 68.3 | 3.7 | 69.0 | 59.0 | 77.0 | -0.3 | -1.2 | 0.7 | 0.372 | | Weight (lbs) | 189 | 186.7 | 37.8 | 185.0 | 97.9 | 285.0 | 96 | 192.6 | 40.4 | 190.0 | 113.0 | 300.0 | -6.0 | -15.7 | 3.8 | 0.148 | | Female | | | | | | | | | | | | | | | | | | Age (years) | 86 | 42.3 | 6.4 | 42.0 | 28.0 | 64.0 | 38 | 45.4 | 9.1 | 45.5 | 29.0 | 63.0 | -3.1 | -6.3 | 0.1 | 0.015 | | BMI (kg/m2) | 86 | 28.1 | 6.0 | 26.6 | 17.1 | 39.1 | 38 | 29.3 | 6.5 | 27.8 | 18.8 | 39.8 | -1.3 | -3.7 | 1.2 | 0.157 | | Height (in) | 86 | 64.9 | 3.0 | 65.0 | 56.0 | 72.0 | 38 | 65.2 | 2.9 | 65.0 | 59.0 | 71.0 | -0.3 | -1.4 | 0.8 | 0.360 | | Weight (lbs) | 86 | 167.7 | 35.3 | 162.5 | 97.9 | 247.0 | 38 | 177.7 | 44.0 | 172.5 | 113.0 | 266.4 | -10.0 | -25.9 | 5.9 | 0.191 | | Male | | | | | | | | | | | | | | | | | | Age (years) | 103 | 46.6 | 9.7 | 46.0 | 22.0 | 67.0 | 58 | 47.1 | 9.3 | 45.0 | 32.0 | 69.0 | -0.4 | -3.4 | 2.6 | 0.499 | | BMI (kg/m2) | 103 | 28.5 | 4.2 | 27.8 | 19.4 | 38.4 | 58 | 28.7 | 4.3 | 28.5 | 20.1 | 39.6 | -0.2 | -1.6 | 1.2 | 0.293 | | Height (in) | 103 | 70.6 | 2.5 | 70.0 | 64.0 | 77.0 | 58 | 70.3 | 2.7 | 70.0 | 65.0 | 77.0 | 0.3 | -0.5 | 1.1 | 0.172 | | Weight (lbs) | 103 | 202.5 | 32.3 | 195.0 | 116.6 | 285.0 | 58 | 202.4 | 34.8 | 196.5 | 124.2 | 300.0 | 0.1 | -10.8 | 11.0 | 0.487 | | Clinical Scores | | | | | | | | | | | | | | | | | | NDI | 189 | 57.4 | 15.9 | 56.0 | 30.0 | 96.0 | 96 | 54.9 | 13.9 | 55.0 | 30.0 | 88.0 | 2.6 | -1.0 | 6.1 | 0.101 | | VAS Neck Pain | 189 | 73.6 | 19.7 | 75.0 | 3.0 | 100.0 | 96 | 74.3 | 20.6 | 77.5 | 0.0 | 100.0 | -0.7 | -5.7 | 4.3 | 0.253 | | VAS Right Arm Pain | 189 | 44.9 | 36.4 | 53.0 | 0.0 | 100.0 | 96 | 44.1 | 37.6 | 48.0 | 0.0 | 100.0 | 0.7 | -8.4 | 9.9 | 0.419 | | VAS Left Arm Pain | 189 | 51.9 | 36.1 | 66.0 | 0.0 | 100.0 | 96 | 52.4 | 34.5 | 61.0 | 0.0 | 100.0 | -0.5 | -9.1 | 8.1 | 0.471 | | DHI Score | 188 | 6.6 | 10.9 | 2.0 | 0.0 | 64.0 | 96 | 5.5 | 10.5 | 2.0 | 0.0 | 54.0 | 1.1 | -1.5 | 3.7 | 0.105 | | SF-12v2 PCS | 189 | 34.7 | 7.0 | 34.8 | 13.8 | 51.8 | 96 | 34.8 | 6.7 | 34.8 | 18.6 | 53.6 | -0.1 | -1.8 | 1.6 | 0.488 | | SF-12v2 MCS | 189 | 45.6 | 11.5 | 45.8 | 18.2 | 67.1 | 96 | 45.8 | 11.7 | 47.0 | 18.6 | 66.7 | -0.2 | -3.0 | 2.7 | 0.425 | | *Device group mean differences and 95% Confidence Intervals with Wilcoxon p-valueSource: Tables Baseline Demo.sas; Analyzed: 19JUN2026 | | | | | | | | | | | | | | | | | PMA 250042: FDA Summary of Safety and Effectiveness Data 31 of 147 {31} Table 9 Summary of Baseline and Demographic Categorical Variables – mITT Analysis Set | | BAGUERA® C | | | Mobi-C | | | Group Difference | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | N | n | % | N | n | % | Dif | 95% LB | 95% UB | | Sex | | | | | | | | | | | Female | 189 | 86 | 45.5% | 96 | 38 | 39.6% | 5.9% | -6.2% | 18.0% | | Male | 189 | 103 | 54.5% | 96 | 58 | 60.4% | -5.9% | -18.0% | 6.2% | | Race | | | | | | | | | | | American Indian or Alaska Native | 189 | 3 | 1.6% | 96 | 1 | 1.0% | 0.5% | -2.2% | 3.2% | | Asian | 189 | 6 | 3.2% | 96 | 0 | 0.0% | 3.2% | 0.7% | 5.7% | | Black or African American | 189 | 9 | 4.8% | 96 | 1 | 1.0% | 3.7% | 0.1% | 7.4% | | Native Hawaiian or Other Pacific Islander | 189 | 0 | 0.0% | 96 | 1 | 1.0% | -1.0% | -3.1% | 1.0% | | White | 189 | 169 | 89.4% | 96 | 93 | 96.9% | -7.5% | -13.1% | -1.9% | | Other | 189 | 2 | 1.1% | 96 | 0 | 0.0% | 1.1% | -0.4% | 2.5% | | Ethnicity | | | | | | | | | | | Hispanic or Latino | 189 | 15 | 7.9% | 96 | 5 | 5.2% | 2.7% | -3.2% | 8.6% | | Not Hispanic or Latino | 189 | 174 | 92.1% | 96 | 91 | 94.8% | -2.7% | -8.6% | 3.2% | | Nurick Classification1 | | | | | | | | | | | 0 | 189 | 150 | 79.4% | 96 | 85 | 88.5% | -9.2% | -17.8% | -0.6% | | 1 | 189 | 27 | 14.3% | 96 | 9 | 9.4% | 4.9% | -2.8% | 12.6% | | 2 | 189 | 7 | 3.7% | 96 | 2 | 2.1% | 1.6% | -2.3% | 5.5% | | 3 | 189 | 4 | 2.1% | 96 | 0 | 0.0% | 2.1% | 0.1% | 4.2% | | 4 | 189 | 0 | 0.0% | 96 | 0 | 0.0% | 0.0% | 0.0% | 0.0% | | 5 | 189 | 1 | 0.5% | 96 | 0 | 0.0% | 0.5% | -0.5% | 1.6% | | Symptomatic Cervical Disc Diagnosis | | | | | | | | | | | No | 189 | 0 | 0.0% | 96 | 0 | 0.0% | 0.0% | 0.0% | 0.0% | | Yes | 189 | 189 | 100.0% | 96 | 96 | 100.0% | 0.0% | 0.0% | 0.0% | | Cervical Radiculopathy Diagnosis | | | | | | | | | | | No | 189 | 11 | 5.8% | 96 | 2 | 2.1% | 3.7% | -0.7% | 8.1% | | Yes | 189 | 178 | 94.2% | 96 | 94 | 97.9% | -3.7% | -8.1% | 0.7% | | Cervical Myelo-Radiculopathy Diagnosis | | | | | | | | | | | No | 189 | 161 | 85.2% | 96 | 85 | 88.5% | -3.4% | -11.5% | 4.8% | | Yes | 189 | 28 | 14.8% | 96 | 11 | 11.5% | 3.4% | -4.8% | 11.5% | | Previous Spine Surgeries | | | | | | | | | | | No | 189 | 165 | 87.3% | 96 | 77 | 80.2% | 7.1% | -2.2% | 16.4% | | Yes | 189 | 24 | 12.7% | 96 | 19 | 19.8% | -7.1% | -16.4% | 2.2% | | Relevant General Medical Conditions | | | | | | | | | | | No | 189 | 41 | 21.7% | 96 | 23 | 24.0% | -2.3% | -12.6% | 8.1% | | Yes | 189 | 148 | 78.3% | 96 | 73 | 76.0% | 2.3% | -8.1% | 12.6% | PMA 250042: FDA Summary of Safety and Effectiveness Data 32 of 147 {32} | | BAGUERA® C | | | Mobi-C | | | Group Difference | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | N | n | % | N | n | % | Dif | 95% LB | 95% UB | | Current Medications for Cervical Spine | | | | | | | | | | | No | 189 | 48 | 25.4% | 96 | 24 | 25.0% | 0.4% | -10.3% | 11.1% | | Yes | 189 | 141 | 74.6% | 96 | 72 | 75.0% | -0.4% | -11.1% | 10.3% | | 1 Nurick Classification (Nurick, 1972): (0) Signs or symptoms of root involvement but without evidence of spinal cord disease; (1) Signs of spinal cord disease but no difficulty in walking; (2) Slight difficulty in walking which did not prevent full-time employment; (3) Difficulty in walking which prevented full-time employment or the ability to do all housework, but which was not so severe as to require someone else's help to walk; (4) Able to walk only with someone else's help or with the aid of a frame; (5) Chair bound or bedridden; Source: Tables Baseline Demo.sas; Analyzed: 19JUN2026 | | | | | | | | | | Table 10 Baseline Work Status (Categorical). mITT Analysis Set | | BAGUERA® C | | | Mobi-C | | | Group Difference | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | N | n | % | N | n | % | Dif | 95% LB | 95% UB | | Preoperative Disability Status | | | | | | | | | | | No | 189 | 178 | 94.2% | 96 | 90 | 93.8% | 0.4% | -5.5% | 6.3% | | Yes | 189 | 11 | 5.8% | 96 | 6 | 6.3% | -0.4% | -6.3% | 5.5% | | Preoperative Work Status | | | | | | | | | | | Not working due to neck problem | 189 | 11 | 5.8% | 96 | 10 | 10.4% | -4.6% | -11.6% | 2.4% | | Not working voluntarily (retired, student, unemployed, etc.) | 189 | 20 | 10.6% | 96 | 7 | 7.3% | 3.3% | -3.5% | 10.1% | | Not working other than neck problems (describe) | 189 | 4 | 2.1% | 96 | 1 | 1.0% | 1.1% | -1.8% | 4.0% | | Working part time due to neck problem | 189 | 4 | 2.1% | 96 | 3 | 3.1% | -1.0% | -5.0% | 3.0% | | Working part time voluntarily | 189 | 6 | 3.2% | 96 | 6 | 6.3% | -3.1% | -8.5% | 2.4% | | Working full time | 189 | 143 | 75.7% | 96 | 68 | 70.8% | 4.8% | -6.1% | 15.8% | | Other | 189 | 1 | 0.5% | 96 | 1 | 1.0% | -0.5% | -2.8% | 1.8% | | Source: Tables Baseline Demo.sas; Analyzed: 19JUN2026 | | | | | | | | | | The tables below provide a summary of intraoperative surgical variables for subjects treated in the study for both the investigational and control groups in the mITT Analysis Set. Variables summarized include operative time, blood loss and length of stay. There was a statistically significant difference in estimated blood loss, in favor of BAGUERA® C in the female subgroup. PMA 250042: FDA Summary of Safety and Effectiveness Data 33 of 147 {33} Table 11 Operative Continuous Variables. mITT Analysis Set | | BAGUERA® C | | | | | | Mobi-C | | | | | | Group Difference* | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | N | Mean | SD | Med | Min | Max | N | Mean | SD | Med | Min | Max | Δ | LB | UB | p | | All | | | | | | | | | | | | | | | | | | Duration of Surgery (min) | 189 | 61.7 | 21.4 | 57.0 | 30.0 | 138.0 | 96 | 61.0 | 20.4 | 56.5 | 24.0 | 156.0 | 0.7 | -4.4 | 5.8 | 0.493 | | Estimated Blood Loss (cc) | 189 | 24.5 | 15.8 | 20.0 | 2.0 | 100.0 | 96 | 27.1 | 15.7 | 25.0 | 5.0 | 90.0 | -2.6 | -6.5 | 1.3 | 0.055 | | Hospital Length of Stay (days) | 189 | 0.1 | 0.5 | 0.0 | 0.0 | 5.0 | 96 | 0.1 | 0.6 | 0.0 | 0.0 | 5.0 | 0.0 | -0.1 | 0.1 | 0.360 | | Female | | | | | | | | | | | | | | | | | | Duration of Surgery (min) | 86 | 57.9 | 20.6 | 53.0 | 30.0 | 138.0 | 38 | 58.0 | 17.6 | 51.5 | 24.0 | 97.0 | -0.2 | -7.2 | 6.9 | 0.346 | | Estimated Blood Loss (cc) | 86 | 23.9 | 15.5 | 20.0 | 5.0 | 75.0 | 38 | 29.2 | 17.3 | 25.0 | 5.0 | 90.0 | -5.2 | -11.6 | 1.2 | 0.027 | | Male | | | | | | | | | | | | | | | | | | Duration of Surgery (min) | 103 | 65.0 | 21.5 | 64.0 | 30.0 | 119.0 | 58 | 62.9 | 21.9 | 58.5 | 25.0 | 156.0 | 2.0 | -5.0 | 9.0 | 0.287 | | Estimated Blood Loss (cc) | 103 | 25.0 | 16.2 | 25.0 | 2.0 | 100.0 | 58 | 25.8 | 14.5 | 22.5 | 5.0 | 50.0 | -0.8 | -5.7 | 4.1 | 0.347 | | *Device group mean differences and 95% Confidence Intervals with Wilcoxon p-value Source: Tables Operative 1L.sas; Analyzed: 19JUN2026 | | | | | | | | | | | | | | | | | As evidenced in Table 12 below, the majority of procedures occurred at C5-C6 and C6-C7 for both the BAGUERA® C Cervical Disc Prosthesis subjects and the Mobi-C control subjects. Table 12 Operative Characteristics (Categorical). mITT Analysis Set | | BAGUERA -C | | | Mobi-C | | | Group Difference | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | N | n | % | N | n | % | Diff. | 95% LB | 95% UB | | Levels Treated | | | | | | | | | | | C3-C4 | 189 | 3 | 1.6% | 96 | 5 | 5.2% | -3.6% | -8.4% | 1.2% | | C4-C5 | 189 | 13 | 6.9% | 96 | 4 | 4.2% | 2.7% | -2.7% | 8.1% | | C5-C6 | 189 | 99 | 52.4% | 96 | 49 | 51.0% | 1.3% | -10.9% | 13.6% | | C6-C7 | 189 | 74 | 39.2% | 96 | 38 | 39.6% | -0.4% | -12.4% | 11.6% | | Source: Tables Operative 1L.sas; Analyzed: 19JUN2026 | | | | | | | | | | As demonstrated above, the investigational subjects and control subjects that make up the mITT analysis population are not significantly different with respect to baseline variables. PMA 250042: FDA Summary of Safety and Effectiveness Data 34 of 147 {34} #### 4. Safety and Effectiveness Results # a) Safety Results The analysis of safety was based on the investigational cohort of 189 BAGUERA® C subjects and 96 control subjects through Month 24 evaluation. The key safety outcomes for this study are presented below in Tables 13 to 23. Adverse effects are reported in Tables 14 to 21. # Adverse Event Summary The CEC reviewed all safety events for both treatment groups, including AEs and SSIs, to allow for uniform adjudication of study-related events and evaluations and to eliminate any site-by-site variations in reporting. Specifically, the CEC reviewed and adjudicated procedure and implant-relatedness, seriousness, and if serious, whether the event was unanticipated. Table 13 shows a summary of AE categories and rates between the investigational and control groups in the AT Analysis Set. Overall, similar rates of AEs occurred in the investigational group (61.9% - 117/189) and control group (69.8% - 67/96). SAEs that were considered “definitely” device-related were also comparable between the two groups, where 0% (0/189) of investigational subjects had “definitely” device-related SAEs, while 2.1% (2/96) control subjects had “definitely” device-related SAEs. Lastly, the rate of SAEs that were considered “definitely” procedure-related was 1.1% (2/189) in investigational subjects and 1.0% (1/96) in control subjects. PMA 250042: FDA Summary of Safety and Effectiveness Data 35 of 147 {35} Table 13 Adverse Event Summary – AT Analysis Set (n=285) | | BAGUERA® C (N = 189) | | | Mobi-C (N = 96) | | | | --- | --- | --- | --- | --- | --- | --- | | | Events | Subjs | %^{1} | Events | Subjs | %^{1} | | All | 335 | 117 | 61.9% | 164 | 67 | 69.8% | | Device Related^{†} | 15 | 12 | 6.3% | 10 | 9 | 9.4% | | Device Related - Possibly | 13 | 10 | 5.3% | 5 | 5 | 5.2% | | Device Related - Probably | 2 | 2 | 1.1% | 1 | 1 | 1.0% | | Device Related - Definitely | 0 | 0 | 0.0% | 4 | 3 | 3.1% | | Procedure Related^{†} | 53 | 40 | 21.2% | 26 | 20 | 20.8% | | Procedure Related - Possibly | 21 | 17 | 9.0% | 8 | 7 | 7.3% | | Procedure Related - Probably | 4 | 4 | 2.1% | 1 | 1 | 1.0% | | Procedure Related - Definitely | 28 | 24 | 12.7% | 17 | 13 | 13.5% | | Device or Procedure Related^{†} | 61 | 43 | 22.8% | 28 | 21 | 21.9% | | Serious Adverse Events | | | | | | | | All | 71 | 51 | 27.0% | 28 | 23 | 24.0% | | Device Related^{†} | 8 | 8 | 4.2% | 5 | 4 | 4.2% | | Device Related - Possibly | 6 | 6 | 3.2% | 1 | 1 | 1.0% | | Device Related - Probably | 2 | 2 | 1.1% | 1 | 1 | 1.0% | | Device Related - Definitely | 0 | 0 | 0.0% | 3 | 2 | 2.1% | | Procedure Related^{†} | 5 | 5 | 2.6% | 7 | 6 | 6.3% | | Procedure Related - Possibly | 2 | 2 | 1.1% | 5 | 4 | 4.2% | | Procedure Related - Probably | 1 | 1 | 0.5% | 1 | 1 | 1.0% | | Procedure Related - Definitely | 2 | 2 | 1.1% | 1 | 1 | 1.0% | | Device or Procedure Related^{†} | 11 | 11 | 5.8% | 7 | 6 | 6.3% | | AE by Severi…