# K202836: GX Navigation Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Aug 19, 2021 after 328 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: 22 generations back to K040583 (2004). 583 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 585 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170679: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems, Medtronic Sofamor Danek (2017) Summary page 4.
- K111953: Nautilus Spinal System, Life Spine (2012) Summary page 4.
- K132760: Nautilus Spinal System, Life Spine, Inc. (2013) Summary page 4.
- K151196: Nautilus Spinal System, Life Spine, Inc. (2015) Summary page 4.
- K200070: ARx Spinal System, Life Spine, Inc. (2020) Summary page 4.
- K191575: ARx Spinal System, Life Spine, Inc. (2019) Summary page 4.

## Most influential descendants
- K260571: SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (2026), 0 descendants of its own

## Indications for use
The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These 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. The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARX Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T System.

Source page: https://510kreport.com/device/K202836
Methodology: https://510kreport.com/methodology