The Virage® OCT Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Virage® OCT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, The Virage® OCT Spinal Fixation System may be connected to the Vital Spinal Fixation System offered by Highridge Medical, using rod connectors and transition rods. Refer to the Vital Spinal Fixation System package insert for a list of the system specific indications of use. The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

Device Description

The Virage® OCT Spinal Fixation System is a posterior fixation system intended to provide immobilization and stabilization of the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.

The Virage® System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Virage® OCT Spinal Fixation System focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an Artificial Intelligence (AI)/Machine Learning (ML) device.

Therefore, many of the requested criteria, such as those pertaining to AI model performance (sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance), are not applicable to this submission. This document describes a traditional 510(k) for a spinal fixation system, not an AI/ML diagnostic or therapeutic device.

However, I can extract the information that is relevant and state where the requested information is not applicable based on the provided document.

Analysis of Acceptance Criteria and Device Performance (Based on Provided Document)

The Virage® OCT Spinal Fixation System is a physical medical device (spinal fixation system), not an AI/ML software device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical testing and usability assessments to demonstrate substantial equivalence to a predicate device, not evaluation of an AI model's diagnostic or predictive performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Goals)	Reported Device Performance (Conclusion)
Mechanical Performance	Meet ASTM F1717 standards (Static Torsion, Dynamic/Static Compression Bending for Spinal Implant Constructs in Vertebrectomy Mode)	"Mechanical testing and usability were evaluated, which all met the acceptance criteria for the worst-case subject connectors."
	Meet ASTM F1798 standards (Axial/Torsional Grip Testing for Static and Fatigue Properties of Interconnection Mechanisms)	"Mechanical testing and usability were evaluated, which all met the acceptance criteria for the worst-case subject connectors."
Usability	Device is usable as intended.	"Mechanical testing and usability were evaluated, which all met the acceptance criteria..."
Packaging	Packaging integrity and safety maintained.	"...packaging, cleaning and sterilization were evaluated to determine no risks were introduced to the system."
Cleaning and Sterilization	Device can be effectively cleaned and sterilized.	"...packaging, cleaning and sterilization were evaluated to determine no risks were introduced to the system."
Risk Assessment	Risks are reduced as low as reasonably practicable, and no equally severe/probable alternative risks exist.	"A risk assessment was conducted that found risks have been reduced as far as possible and neither alternative design nor therapeutic options exist to avoid the introduced risks without introducing equally severe and/or probable risks."
Substantial Equivalence	Demonstrate substantial equivalence to the predicate Virage® System (K153631) regarding intended use, indications for use, design, materials, manufacturing methods, fundamental technology, and operational principles.	"The Virage® System's indications for use, intended use, design, materials, and performance assessments are substantially equivalent to the currently marketed Virage® System. As such, Highridge Medical, LLC concludes that the subject Virage® System is substantially equivalent to the predicate Virage® System."
MRI Compatibility	Meet ASTM F2052 (magnetically induced displacement force), ASTM F2182 (RF induced heating), ASTM F2213 (magnetically induced torque), and ASTM F2119 (MR image artifacts).	"Based on testing of the Virage® System in a magnetic resonance environment, the labeling was updated to include the addition of 'MR Conditional information'."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The document refers to "worst-case subject connectors" for mechanical testing, implying specific samples of the device components were tested, but not a "test set" of patient data or images.
Data Provenance: Not applicable. The "data" are mechanical test results, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This is a physical device, not an AI/ML diagnostic tool that requires expert-established ground truth from images or patient data. Ground truth for mechanical testing would be defined by engineering specifications and standard test methods.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are for human expert consensus on medical images or patient outcomes, which is not relevant for mechanical testing of a spinal implant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is used to evaluate the impact of an AI/ML system on human reader performance for tasks like diagnosis or detection. This is a mechanical device, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

Not Applicable. This is a physical spinal implant, not a standalone algorithm.

7. The type of Ground Truth Used

Mechanical Test Standards and Engineering Specifications: The "ground truth" for this device's performance evaluation is adherence to standardized mechanical testing protocols (ASTM F1717, ASTM F1798) and internal engineering specifications for safety and performance, demonstrating equivalence to the predicate device.
MRI Compatibility Standards: Compliance with relevant ASTM standards for MRI compatibility (F2052, F2182, F2213, F2119) serves as the ground truth for this aspect.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary

FDA 510(k) Clearance Letter - Virage® OCT Spinal Fixation System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 4, 2025

Highridge Medical, LLC
Regan Ream
Regulatory Affairs Senior Specialist
10225 Westmoor Drive
Westminster, Colorado 80021

Re: K250332
Trade/Device Name: Virage® OCT Spinal Fixation System
Regulation Number: 21 CFR 888.3075
Regulation Name: Posterior cervical screw system
Regulatory Class: Class II
Product Code: NKG, KWP
Dated: February 4, 2025
Received: February 5, 2025

Dear Regan Ream:

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 (the 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 available 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. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

K250332 – Regan Ream Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Page 3

K250332 – Regan Ream Page 3

Sincerely,

Colin O'neill -S

Colin O'Neill, M.B.E.
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K250332

Device Name
Virage® OCT Spinal Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) K250332 Page 1 of 1

Page 5

Highridge Medical (Zimmer Biomet Spine)

Traditional 510(k) Premarket Notification

Highridge Medical (Zimmer Biomet Spine) Confidential
10225 Westmoor Drive
Westminster, CO 80021

510(k) Summary
K250332 Page 1 of 3

4/4/2025

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Sponsor Information

Field	Information
Name	Highridge Medical, LLC (Zimmer Biomet Spine, Inc.)
Address	10225 Westmoor Dr.Westminster, CO 80021
Establishment Registration	3012447612
Contact Person(s)	Regan ReamRegulatory Affairs Senior SpecialistPhone: (720) 227.2187Email: Regan.Ream@highridgemedical.comAnjanet MortRegulatory Affairs ManagerPhone: (720) 839.7926Email: Anjanet.Mort2@highridgemedical.com

Device Information

Field	Information
Proprietary Name	Virage® OCT Spinal Fixation System
Common Name	Posterior Cervical Screw System
Device Class	Class II
Device Panel	Orthopedic Panel (87)
Regulation Number	21 CFR § 888.307521 CFR § 888.3050
Classification Name-Product Code(s)	Posterior Cervical Screw System (NKG)Appliance, Fixation, Spinal Interlaminal (KWP)
Predicate Devices	Primary Predicate: Virage® System (K153631)

Device Description

Page 6

Highridge Medical (Zimmer Biomet Spine)

Traditional 510(k) Premarket Notification

Intended Use / Indications for Use

In order to achieve additional levels of fixation, The Virage® OCT Spinal Fixation System may be connected to the Vital Spinal Fixation System offered by Highridge Medical, using rod connectors and transition rods. Refer to the Vital Spinal Fixation System package insert for a list of the system specific indications of use. The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral fixation (T8‑L5).

Substantial Equivalence Assessment

The technological characteristics of the subject Virage® System components remain the same as, or similar to, the predicate Virage® System (K153631) in regard to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles. The purpose of this submission is to seek clearance of additional rod-to-rod connectors for use with the Virage® System and the MRI conditional information provided and references to the Reusable Lifespan Manual in the Instructions for Use for the Virage® System. Additionally, this submission discloses various minor changes to the previously cleared Virage® System that were introduced via Letters-to-File.

Specifically, the subject Virage® System is manufactured using the same materials and processes used to manufacture the previously cleared Virage® System. Additionally, the subject devices have the same intended use as the predicate devices. As such, the performance assessments of the subject devices are substantially equivalent to the predicate devices. Furthermore, the subject Virage® System has the same methods and technological characteristics as its cleared predicate Virage® System (K153631).

MRI Compatibility

Previously, labeling for the Virage® System indicated that the system had not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The following MR environment testing was evaluated:

ASTM F2052: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
ASTM F2213: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F2119: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

Based on testing of the Virage® System in a magnetic resonance environment, the labeling was updated to include the addition of "MR Conditional information". For additional information, See Electromagnetic Compatibility and Labeling.

Page 7

Highridge Medical (Zimmer Biomet Spine)

Traditional 510(k) Premarket Notification

Highridge Medical (Zimmer Biomet Spine) Confidential
10225 Westmoor Drive
Westminster, CO 80021

510(k) Summary
K250332 Page 3 of 3

Reusable Lifespan Manual

The Reusable Lifespan Manual (See Labeling) is intended to assist the user in determining whether a reusable instrument is no longer suitable for use. This manual provides supplemental information to the Virage® System IFU; however, is not specific to the Virage® System. This manual is included in this submission as a reference only, as the Virage System Instructions For Use were updated to include references to the Reusable Lifespan Manual. Upon clearance of this 510k, physicians can access the Reusable Lifespan Manual via the Highridge Medical labeling website (ifu.highridgemedical.com).

Performance Testing Conclusion

Mechanical testing and usability were evaluated, which all met the acceptance criteria for the worst-case subject connectors. Additionally, packaging, cleaning and sterilization were evaluated to determine no risks were introduced to the system.

Static torsion and dynamic/static compression bending was performed in accordance with ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Mode (Recognition Number: 11-388). Axial/Torsional grip testing was performed in accordance with ASTM F1798 Standard Test Methods for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (Recognition Number: 11-402).

A risk assessment was conducted that found risks have been reduced as far as possible and neither alternative design nor therapeutic options exist to avoid the introduced risks without introducing equally severe and/or probable risks.

Substantial Equivalence Conclusion

The Virage® System's indications for use, intended use, design, materials, and performance assessments are substantially equivalent to the currently marketed Virage® System. As such, Highridge Medical, LLC concludes that the subject Virage® System is substantially equivalent to the predicate Virage® System.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.