Patriot-SI Posterior Implant System— 510(k) K232259

Name: FDA 510(k) clearance K232259
Creator: U.S. Food and Drug Administration
Published: 2024-04-19

Substantially Equivalent

Spinal Simplicity, LLC

FDA 510(k) clearance K232259 for Patriot-SI Posterior Implant System, Substantially Equivalent on 2024-04-19. Applicant: Spinal Simplicity, LLC. Device class: 2.

Clearance details

Applicant: Spinal Simplicity, LLC
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2023-07-31
Decision date: 2024-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

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K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

More clearances from Spinal Simplicity, LLC

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K253250 — Minuteman® G6 MIS Fusion Plate2025-12-01
K250001 — Patriot SI Implant System2025-06-03
K240592 — Wolff's Law Anterior Cervical Plate System2024-05-24
K234051 — Minuteman G5 MIS Fusion Plate +3 more2024-01-18
K231923 — Liberty SI Lateral Implant System2023-12-05

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.