Cleared Traditional

Patriot-SI Posterior Implant System (K232259) - FDA 510(k) Clearance

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

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

K232259 is an FDA 510(k) clearance for the Patriot-SI Posterior 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 April 19, 2024 after a review of 263 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 K232259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 122d · This submission: 263d
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 K232259.
iFuse TORQ® Implant System
K241574 · SI-BONE, Inc. · Jul 2024
Eminent Spine SI Screw System
K240505 · Eminent Spine, LLC · Jun 2024
BowTie™ SI Joint Fusion System
K232149 · Sail Fusion, LLC · Apr 2024
TiLink-P SI Joint Fusion System
K240720 · SurGenTec, LLC · Apr 2024
Camber Sacroiliac (SI) Fixation System
K233972 · Camber Spine Technologies · Feb 2024
PathLoc SI Joint Fusion System
K240201 · L & K Biomed Co., Ltd. · Feb 2024