Cleared Traditional

TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); 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 · TriMed, Inc. · Orthopedic

Jun 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K250929 is an FDA 510(k) clearance for the TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); 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), a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on June 26, 2025, 90 days after receiving the submission on March 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K250929 FDA.gov
FDA Decision	Cleared 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