# K240647: Virage® Navigation System

- Pathway: 510(k) (Special)
- Applicant: Zimvie Spine (Zimmer Biomet Spine, Inc.)
- Decided: Apr 5, 2024 after 29 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K862807 (1986). 70 ancestors in all.
No later device cites it as a predicate yet.
2 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212023: Virage Navigation System, Zimmer Biomet Spine, Inc. (2021) Summary page 4.

## Indications for use
The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab Navigation System.

Source page: https://510kreport.com/device/K240647
Methodology: https://510kreport.com/methodology