# K250001: Patriot SI Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Simplicity, LLC
- Decided: Jun 3, 2025 after 152 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 125 ancestors in all.
No later device cites it as a predicate yet.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232259: Patriot-SI Posterior Implant System, Spinal Simplicity, LLC (2024) Summary page 5.

## Indications for use
The Patriot Sl Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K250001
Methodology: https://510kreport.com/methodology