Cleared Traditional

Patriot SI Implant System (K250001) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250001 · Spinal Simplicity, LLC · Orthopedic device
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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

Submission Details

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.

Device Classification

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 99
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