Virage Navigation System
by Zimvie Spine (Zimmer Biomet Spine, Inc.) 510(k)
Active
510(k) K240647
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240647 | Date5 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- OLO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Virage Navigation System is an orthopedic stereotaxic instrument designed for precise surgical navigation. It assists in the accurate placement of spinal implants by providing real-time guidance during procedures, enhancing procedural safety and efficacy. This system integrates with imaging technologies to offer enhanced visualization and control, supporting complex spinal interventions. Its classification aligns with FDA-defined orthopedic stereotaxic instruments, ensuring compliance with regulatory standards for spinal surgical aids.
The device is supplied as a reusable medical instrument, intended for use in sterile operating room environments. It is regulated under 21 CFR 882.4560 as a Class II orthopedic stereotaxic instrument, with FDA clearance via a 510(k) submission (K240647). Storage and handling follow standard sterile instrument protocols, and its design adheres to orthopedic navigation systems approved for neurology-related spinal procedures. No additional sterility claims or single-use specifications are stated in the regulatory data.
Other devices from Zimvie Spine (Zimmer Biomet Spine, Inc.)
Questions
AI-generated answers, 1 Oct 2026
What is the Virage Navigation System used for?
The Virage Navigation System is designed for orthopedic stereotaxic guidance during spinal surgeries. It provides real-time visualization and control to assist in the accurate placement of spinal implants, improving procedural safety and outcomes for complex spinal interventions. The system integrates with imaging technologies to offer enhanced precision, particularly in neurology-related spinal procedures.
Is the Virage Navigation System reusable or single-use?
The Virage Navigation System is supplied as a reusable medical instrument. It is intended for use in sterile operating room environments, following standard sterile instrument protocols for storage and handling. No single-use specifications are stated in the regulatory data.
How is sterility maintained for the Virage Navigation System?
Sterility for the Virage Navigation System is maintained through adherence to standard sterile instrument protocols. Since it is reusable, it must be properly cleaned, sterilized, and stored in a controlled environment to ensure it remains sterile for subsequent surgical use. The manufacturer provides guidelines for storage and handling to comply with these requirements.
What regulatory approval does the Virage Navigation System hold?
The Virage Navigation System holds FDA clearance via a 510(k) submission (K240647). It is classified as a Class II orthopedic stereotaxic instrument under 21 CFR 882.4560, with a decision of substantial equivalence to a predicate device. The clearance was granted through a special review process by the Orthopedic Devices Advisory Committee.
What types of spinal procedures does the Virage Navigation System support?
The Virage Navigation System is designed to support complex spinal interventions, particularly those involving neurology-related procedures. Its integration with imaging technologies allows for enhanced visualization and control, aiding in the precise placement of spinal implants. This makes it suitable for surgeries requiring high accuracy and safety.