(58 days)
Not Found
No
The provided text describes a medical device, the Virage® OCT Spinal Fixation System, which is a physical implant used for spinal stabilization. The description focuses on its components, materials, and intended use as an adjunct to spinal fusion. There is absolutely no mention or indication of any computational, software, or data processing functions, let alone artificial intelligence, machine learning, or deep neural networks.
Yes
This device, the Virage® OCT Spinal Fixation System, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities, including traumatic fractures, deformities, failed fusions, tumors, and degenerative disease. These are all conditions that affect the body's structure and function, and the device is used to treat or alleviate these conditions.
No
This device is a spinal fixation system, which is a surgical implant intended to provide stability to the spine as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the Virage® OCT Spinal Fixation System consists of "a variety of rods, anchors, connectors, screws, and polyaxial screws," and that "The Virage® System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy." It also mentions "instruments necessary for inserting and securing the implants." These are all tangible hardware components, clearly indicating it is not a software-only medical device.
No.
The device is a spinal fixation system, which is an implantable medical device used for stabilization of spinal segments. It is not designed to perform tests on specimens derived from the human body.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, cervical spine (C1-C7), thoracic spine from T1-T3, Occipital-Cervical-Thoracic spine (Occiput-T3), T1-S2/ilium, T1-L5, T8-L5
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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).
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 Ream |
| Regulatory Affairs Senior Specialist | |
| Phone: (720) 227.2187 | |
| Email: Regan.Ream@highridgemedical.com |
Anjanet Mort
Regulatory Affairs Manager
Phone: (720) 839.7926
Email: 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 § 888.3075 |
| 21 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
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.
Page 6
Highridge Medical (Zimmer Biomet Spine)
Traditional 510(k) Premarket Notification
Intended Use / Indications for Use
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).
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.