# K200719: NuVasive Navigation.S Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Dec 2, 2020 after 258 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: 19 generations back to K003155 (2001). 295 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192336: Navigated Anterolateral Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4.
- K172623: NuVasive Navigation Instruments, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- 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
- K223765: ATEC Lateral Navigation Instruments (2023), 0 descendants of its own

## Indications for use
NuVasive Navigation.S Instruments are intended to be used during the preparation and placement of NuVasive screws (Reline, Reline C, and VuePoint fixation systems) and disc preparation during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated disc preparation instruments are intended to be used to facilitate a discectomy or boney resection during spinal surgery. The navigated trials are intended to be used to facilitate implant size selection of NuVasive intervertebral body fusion devices during spinal surgery. NuVasive Navigation.S 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 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/K200719
Methodology: https://510kreport.com/methodology