MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments
Applicant
Medacta International S.A.
Product Code
PQC · Orthopedic
Decision Date
Apr 19, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Indications for Use
MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: - Drill based - K-wire based MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only.
Device Story
Patient-specific surgical guides; fabricated via additive manufacturing (laser sintering) using medical-grade nylon (PA12). Input: patient spinal CT scans. Process: pre-operative 3D planning software (Mimics, Solidworks) creates vertebral models; guides designed to match patient anatomy. Output: physical guides used intra-operatively by surgeons to reference pedicle screw placement. Function: Drill Pilot guides create pilot holes; MC guides provide drill or K-wire targeting. Used in spinal fusion procedures; guides are single-use. Benefit: precise anatomical referencing for pedicle screw positioning.
Clinical Evidence
No clinical studies were conducted. Evidence is based on non-clinical performance testing, including design validation, stability assessment, post-operative accuracy evaluation, and wear testing.
Technological Characteristics
Patient-specific guides manufactured via additive manufacturing (laser sintering) of medical-grade nylon (PA12). Single-use, non-sterile (sterilized via gamma radiation). Software-driven design based on CT imaging. External communicating device with limited (<24 hours) contact duration.
Indications for Use
Indicated for patients requiring spinal fusion between T1-L5 (Drill Pilot) or L1-S1 (MC) for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, or failed previous fusion.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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April 19, 2018
Medacta International SA % Elizabeth Rose, MST, RAC Manager, Regulatory Affairs - Medical Devices Mapi USA, Inc 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K173472
Trade/Device Name: MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PQC Dated: March 19, 2018 Received: March 19, 2018
Dear Ms. Rose:
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. 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known)
### K173472
### Device Name
MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments
Indications for Use (Describe)
MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.
The device is provided with two options:
- Drill based
· K-wire based
MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.
Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.
MySpine MC and Drill Pilot guides are intended for single use only.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <span style="font-size: 10pt;"> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <span style="font-size: 10pt;"> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 3.0 510(k) Summary
#### I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory Affairs Manager, Medacta International SA Consultant: Elizabeth Rose, Regulatory Affairs Manager, Medical Devices, Mapi USA, Inc. Date Prepared: November 8, 2017 Date Revised: April 19, 2018
#### II. Device
| Device Proprietary Name: | MySpine Pedicle Screw Placement Guides – MC and Drill<br>Pilot Instruments |
|--------------------------|----------------------------------------------------------------------------|
| Common or Usual Name: | Pedicle Screw Placement Guide |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Primary Product Code: | PQC |
| Regulation Number: | 21 CFR 888.3070 |
| Device Classification | II |
#### III. Predicate Device
Substantial equivalence is claimed to the following devices: Primary Predicate
- MySpine Pedicle Screw Placement Guides LP, K153273, Medacta International SA ●
Additional Predicate:
- MySpine Pedicle Screw Placement Guides, K132788, Medacta International SA ●
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#### IV. Device Description
The MySpine Pedicle Screw Placement Guides – MC (Midline Cortical) and Drill Pilot Instruments are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. The MySpine Pedicle Screw Placement Guides – MC and S1 Guide Instruments are for use in spinal levels L5 to S1. The MySpine Pedicle Screw Placement Guides - Drill Pilot Guide Instruments are for use in spinal levels T1 to S1.
The MySpine product line is a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System based on the patient's anatomy. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are intended to be used with Medacta's M.U.S.T. Pedicle Screw System (K121115, K132878, K141988, K153664, K162061, and K171170) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion.
The MySpine platform allows the surgeon to complete pre-operative planning in 3D, based on the patient's spinal CT scans. Medacta International SA uses these images in combination with SW Mimics® (Materialize®) and W Solidworks® (Dassault Systèmes®) to import DICOM images from a patient's CT scans and then process the scans into accurate 3D models. CT imaging is used to create a 3D model of the vertebrae according to the patient's anatomy. The subsequent vertebral model represents the template used to generate the corresponding MySpine Screw Placement Guides to fit the patient's vertebral anatomy.
#### V. Indications for Use
MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use.
MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.
The device is provided with two options:
- · Drill based
- · K-wire based
MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
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MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.
Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.
MySpine MC and Drill Pilot guides are intended for single use only.
#### VI. Comparison of Technological Characteristics
The MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments and the predicate devices share the following characteristics:
- . design;
- software;
- material of construction;
- biocompatibility;
- manufacturing process; ●
- device usage;
- . sterility:
- shelf life; and
- packaging.
The MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments have a different physical profile from the predicate devices.
The MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments are manufactured from medical grade nylon (Polyamide PA12) which is identical to predicate devices, Medacta's MySpine Pedicle Screw Placement Guides (K132788) and MySpine Pedicle Screw Placement Guides - LP (K153273).
Due to the extensive history of use in currently marketed medical devices, as well as similarities in the manufacturing processes between the subject and reference devices, additional biocompatibility testing was deemed unnecessary for the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments.
A comparison of the subject and predicate devices is provided in the table below.
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## Technological comparison
| Parameters | MySpine Pedicle Screw<br>Placement Guides - MC<br>and Drill Pilot Instruments | MySpine Pedicle Screw<br>Placement Guides – LP<br>(K153273) | MySpine Pedicle Screw<br>Placement Guides<br>(K132788) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------|
| Design | Patient specific surgical<br>instruments generated from<br>patient's CT scan | Identical | Identical |
| Software | SW Mimics® (Materialize®)<br>and W Solidworks® (Dassault<br>Systèmes®) | Identical | Identical |
| Physical Profile | Drill Pilot Guides: guide drill<br>to prepare hole for<br>positioning of the pedicle<br>screws<br>MC and S1 Guides:<br>drill based - guide drill to prepare hole for positioning of the pedicle screwsK-wire based - low profile guides | Low Profile | Standard Size |
| Manufacturing<br>Process | Additive manufacturing using<br>a sintering process of medical<br>grade nylon on a laser<br>sintering system. | Identical | Identical |
| Material | Medical Grade Nylon for<br>sintering (PA12 Medical<br>Grade) | Identical | Identical |
| Biocompatibility | External communicating<br>devices with limited (<24<br>hours) contact duration | Identical | Identical |
| Device Usage | Single Use | Identical | Identical |
| Sterility | Gamma Radiation and Non-<br>Sterile | Identical | Identical |
| Shelf Life | 6 months after CT scan | Identical | Identical |
| Packaging | Individual packaging | Identical | Identical |
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## Discussion
There are differences between the subject and predicate devices with respect to the indications for use statement. The subject devices indications for use are being expanded to include lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1 with option of drill based or K-wire based positioning.
The differences in the indications for use and physical profile between the subject and predicate devices do not raise new questions of safety and effectiveness. Medacta International SA has not made any changes to the intended use, materials of construction, design, manufacturing process, software, device usage, or of the subject devices. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments to the identified predicate devices.
#### VII. Performance Data
Risks were identified based on the proposed design and testing was conducted to mitigate those risks. Based on the risk analysis, testing was conducted according to written protocols with acceptance criteria. The following performance data was provided in support of the substantial equivalence determination:
Non-Clinical Studies
- . Performance Tests
- O design validation: validated the design, intended use and procedure;
- stability assessment: verified the stability of contact points related to the degrees O of freedom;
- post-operative evaluation: validated the guide accuracy; and o
- wear test: quantified the debris generated by an instrument during pedicle O preparation and screws insertion, because of moving parts wear.
Clinical Studies
- no clinical studies were conducted. .
## VIII. Conclusion
Based on the above information, the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments can be considered substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are as safe and effective as the
{8}------------------------------------------------
predicate devices, Medacta's MySpine Pedicle Screw Placement Guides (K132788) and MySpine Pedicle Screw Placement Guides – LP (K153273).
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