# K213720: Vital Navigation System

- Pathway: 510(k) (Special)
- Applicant: Zimvie (Zimmer Biomet Spine, Inc.)
- Decided: Jan 7, 2022 after 44 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). 400 ancestors in all.
No later device cites it as a predicate yet.
1 of 401 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.
- K203507: Vitality® Spinal Fixation System, Zimmer Biomet Spine, Inc. (2021) Summary page 4.
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System, Medtronic Navigation, Inc. (2014) Summary page 4.
- K170937: VIPER PRIME navigated inserter, Medos International SARL (2017) Summary page 4.

## Indications for use
Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation 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.

Source page: https://510kreport.com/device/K213720
Methodology: https://510kreport.com/methodology