Cleared Traditional

Patriot SI Implant System

K250001 · Spinal Simplicity, LLC · Orthopedic
Jun 2025
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K250001 is an FDA 510(k) clearance for the Patriot SI Implant System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on June 3, 2025, 152 days after receiving the submission on January 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250001 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2025
Decision Date June 03, 2025
Days to Decision 152 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion