# K203561: ChoiceSpine Navigation System

- Pathway: 510(k) (Special)
- Applicant: Choice Spine, LLC
- Decided: Jan 4, 2021 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: 15 generations back to K841189 (1984). 209 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 211 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182721: Choice Spine Navigation System, Choicespine, LP (2019) Summary page 5.
- K133214: Blackbird Spinal System, Choicespine, LP (2014) Summary page 5.
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K220024: ChoiceSpine Navigation System (2022), 0 descendants of its own

## Indications for use
The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine Lancer™, Thunderbolt™, and Blackbird™ system 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 Stealth Station System (V2.1.0), 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, along 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/K203561
Methodology: https://510kreport.com/methodology