# K220024: ChoiceSpine Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Choice Spine, LLC
- Decided: Jul 6, 2022 after 182 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: 16 generations back to K841189 (1984). 242 ancestors in all.
No later device cites it as a predicate yet.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K203110: iFuse Implant System - iFuse Navigation, SI-BONE, Inc. (2020) Summary page 5.
- K203561: ChoiceSpine Navigation System, Choice Spine, LLC (2021) Summary page 5.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.

## Indications for use
The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine system implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic StealthStation S7 (V2.1.0) and S8 (V1.2.0) systems, which are 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 for the anatomy.

Source page: https://510kreport.com/device/K220024
Methodology: https://510kreport.com/methodology