# K233443: Vital™ Navigation System

- Pathway: 510(k) (Special)
- Applicant: Zimvie Spine (Zimmer Biomet Spine, Inc.)
- Decided: Nov 16, 2023 after 28 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: 18 generations back to K040583 (2004). 388 ancestors in all.
No later device cites it as a predicate yet.
1 of 389 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191722: Vital Navigation System, Zimmer Biomet Spine, Inc. (2019) Summary page 4.

## Indications for use
The Vital Navigation System instruments are used during the preparation and placement of the Vital and Vitality System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System.

Source page: https://510kreport.com/device/K233443
Methodology: https://510kreport.com/methodology