Cleared Traditional

K250001 - Patriot SI Implant System

K250001 is an FDA 510(k) clearance for Patriot SI Implant System, manufactured by Spinal Simplicity, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K250001 · Spinal Simplicity, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
152d
Days
Class 2
Risk

K250001 is an FDA 510(k) clearance for the Patriot SI Implant System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on June 3, 2025 after a review of 152 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinal Simplicity, LLC devices

FDA 510(k) Submission Details - K250001

510(k) Number K250001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 122d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OUR Device Classification - Class 2, Special Controls

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K250001.
The Rialto™ SI Fusion System
K251395 · Medtronic Sofamor Danek USA, Inc. · Jun 2025
Omnia Medical PsiF DNA™ System
K242431 · Omnia Medical, LLC · Jun 2025
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
K251525 · Si-Technology, LLC · Jun 2025
DYNAMIS™ Implant System
K251075 · Promethean Restorative, LLC · Apr 2025
Catamaran SI Joint Fusion System
K250403 · Tenon Medical · Mar 2025
NEXXT MATRIXX® SI System
K243838 · Nexxt Spine · Mar 2025