# K260571: SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Jun 2, 2026 after 103 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: 23 generations back to K040583 (2004). 704 ancestors in all.
No later device cites it as a predicate yet.
3 of 705 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252088: Firebird SI Navigation System, Orthofix US, LLC (2025) Summary page 5.
- K251395: The Rialto™ SI Fusion System, Medtronic Sofamor Danek USA, Inc. (2025) Summary page 5.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.
- K202836: GX Navigation Instrument System, Life Spine, Inc. (2021) Summary page 5.
- K212903: SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2021) Summary page 5.
- K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2020) Summary page 5.
- K180749: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2018) Summary page 5.
- K141246: Life Spine Sacroiliac Joint Fixation System, Life Spine, Inc. (2015) Summary page 5.

## Indications for use
The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are intended to be used during the preparation and placement of the SIMPACT Sacroiliac Joint Fixation System 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® S7 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 the pelvis 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/K260571
Methodology: https://510kreport.com/methodology