# K212023: Virage Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet Spine, Inc.
- Decided: Aug 27, 2021 after 59 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: 12 generations back to K862807 (1986). 69 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173338: Navigated INFINITY™ Instruments, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 4.
- K170011: StealthStation S8 Spine Software v1.0.0, Medtronic Navigation (2017) Summary page 4.

## Most influential descendants
- K240647: Virage® Navigation System (2024), 0 descendants of its own

## 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. The Virage® Navigation System Instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. The Virage® Navigation Instruments are also compatible with the Zimmer Biomet Universal Power System and the WalterLorenz® Surgical Assist Arm.

Source page: https://510kreport.com/device/K212023
Methodology: https://510kreport.com/methodology