TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);

The TriMed Wrist Fixation System comprises multiple anatomically shaped metallic plates, screws, pegs, and wireforms made of 316L stainless steel used to treat fractures, non-unions, and osteotomies of the distal radius and ulna. The system includes volar bearing plates, fixed-angle plates, hook plates, pin plates, peg plates, shear plates, wireforms, and cortical screws in various configurations, all supplied non-sterile for surgical fixation of wrist injuries.

The devices are substantially equivalent to the predicate TriMed Wrist Fixation System 3 in material composition (316L stainless steel per ASTM F138/139), design features, principles of operation, manufacturing, packaging, and labeling. Any differences between the proposed device and predicate device are considered minor and do not raise different safety or effectiveness questions. TriMed Welded Buttress Pins exhibited superior performance during static and endurance testing compared to predicate buttress pins.

ASTM F138/139 material specification for stainless steel; FDA Guidance Document on Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway; performance testing per TRL-69 (Test Report for Static Testing of TriMed Bone Screws – 2.3mm, 2.7mm, 3.2mm); design verification documented in QR-2738 for WS3, WFS, and ROS.

TriMed devices are substantially equivalent because they share identical indications for use with the predicate K222637 (TriMed Wrist Fixation System 3), use the same 316L stainless steel material per ASTM standards, employ identical design principles and principles of operation, and undergo equivalent manufacturing and testing protocols. Worst-case representative devices underwent performance testing showing adequate safety and effectiveness. Any technological differences are minor and do not raise different questions of safety or effectiveness compared to the legally marketed predicate.