Cervical Stand-Alone System

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November 5, 2021 Eminent Spine, LLC % Meredith May, MS, RAC Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918 Re: K212853 Trade/Device Name: Cervical Stand-Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 3, 2021 Received: September 7, 2021 Dear Meredith May: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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Sincerely, Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page. #### 510(k) Number (if known) K212853 Device Name Cervical Stand-Alone System Indications for Use (Describe) The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation. Type of Use (Select one or both, as applicable) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) ∑ Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 510(K) SUMMARY | Submitter's Name: | Eminent Spine, LLC | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address: | 2004 Ventura Drive, Suite 100<br>Plano, Texas 75093 | | Submitter's Telephone: | 972-499-3593 | | Contact Person: | Meredith May MS, RAC<br>Empirical Testing Corp.<br>1-719-337-7579<br>MMay@EmpiricalTech.com<br>Image: Empirical Testing Corp. Logo | | Date Summary was Prepared: | September 3, 2021 | | Trade or Proprietary Name: | Cervical Stand-Alone System | | Common or Usual Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical | | Classification: | Class II per 21 CFR §888.3080 | | Product Code: | OVE | | Classification Panel: | Orthopedic | ## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Cervical Stand-Alone System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. Cervical Stand-Alone devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6A1-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136. These devices are offered non-sterile. ## INDICATIONS FOR USE The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation. ## TECHNOLOGICAL CHARACTERISTICS {4}------------------------------------------------ The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates: - Indications for Use - Materials of manufacture - . Structural support mechanism - Sizes ● #### Table 5-1 Predicate Devices | 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Product<br>Code | Predicate<br>Type | |---------------------|-----------------------------------------------------------------------------------|--------------------------|-----------------|-------------------| | K200115,<br>K173077 | Cavetto®-SA Cervical Cage System | NeuroStructures,<br>Inc. | OVE | Primary | | K200087 | F3D Cervical Stand-Alone Interbody<br>Fusion System | CoreLink, LLC | OVE | Additional | | K132029 | Vault-C Standalone Cervical Interbody<br>Fusion System | Spinal USA, Inc. | OVE | Additional | | K131880 | SpineFrontier® A-CIFT™ SoloFuse™<br>Cervical Intervertebral Body Fusion<br>Device | SpineFrontier,<br>Inc. | OVE | Additional | # PERFORMANCE DATA The Cervical Stand-Alone System has been tested in the following test modes: - Static and dynamic axial compression per ASTM F2077 ● - Static and dynamic compression shear per ASTM F2077 ● - Static and dynamic torsion per ASTM F2077 ● - . Subsidence per ASTM F2267 The results of this non-clinical testing show that the strength of the Cervical Stand-Alone System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. ## CONCLUSION The overall technology characteristics and mechanical performance data lead to the conclusion that the Cervical Stand-Alone System is substantially equivalent to the predicate device.