# K182721: Choice Spine Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Jan 8, 2019 after 102 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: 14 generations back to K841189 (1984). 198 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6.
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems, Choicespine (2014) Summary page 6.

## Most influential descendants
- K203561: ChoiceSpine Navigation System (2021), 1 descendant of its own
- K220024: ChoiceSpine Navigation System (2022), 0 descendants of its own

## Indications for use
The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable 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 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/K182721
Methodology: https://510kreport.com/methodology