Cleared Traditional

K250929 - TriMed Ulnar Osteotomy System (Ulnar Os...

Also marketed or referenced as:
TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm) TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm) TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

K250929 is the FDA 510(k) clearance for TriMed Ulnar Osteotomy System (Ulnar Os... by TriMed, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K250929 · TriMed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
90d
Days
Class 2
Risk

K250929 is an FDA 510(k) clearance for the TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate). Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on June 26, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 TriMed, Inc. devices

Submission Details

510(k) Number K250929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2025
Decision Date June 26, 2025
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K250929.
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
K251945 · TriMed, Inc. · Jul 2025
Genostis Osteosynthesis System
K242988 · Genostis AF · Jun 2025
Equinoxe® Scapula Fracture System
K243275 · Exactech, Inc. · Jun 2025
The Acumed Wrist Fixation System
K251296 · Acumed, LLC · Jun 2025
LORRAINE 2.5/3.5mm Distal Humerus System
K250933 · Bonebridge AG · Jun 2025
Montblanc Plate System
K243368 · Medifield Medical Co., Ltd. · Jun 2025