# K172623: NuVasive Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Dec 21, 2017 after 111 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: 17 generations back to K040583 (2004). 154 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153603: Alphatec Navigation Instruments, Alphatec Spine, Inc. (2016) Summary page 4.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K200719: NuVasive Navigation.S Instruments (2020), 4 descendants of its own
- K180038: NuVasive Pulse System (2018), 3 descendants of its own
- K210574: NuVasive Pulse System (2021), 2 descendants of its own
- K243814: NuVasive Pulse System (2025), 0 descendants of its own
- K230989: Rod Registration Frame (2023), 0 descendants of its own

## Indications for use
NuVasive® Navigation Instruments are intended to be used during the preparation and placement of NuVasive screws (Armada, Reline, Precept, MAS PLIF, and VuePoint fixation systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. NuVasive® Navigation Instruments are 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K172623
Methodology: https://510kreport.com/methodology