Cleared Traditional

Patriot-SI Posterior Implant System

K232259 · Spinal Simplicity, LLC · Orthopedic
Apr 2024
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K232259 is an FDA 510(k) clearance for the Patriot-SI Posterior 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 April 19, 2024, 263 days after receiving the submission on July 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K232259 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2023
Decision Date April 19, 2024
Days to Decision 263 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