TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

The TriMed Total Wrist Fusion System is a metallic bone fixation device made from implant-grade stainless steel, used to fixate bone during treatment of wrist arthrodesis, fractures of the wrist, and osteotomies of the wrist. It functions as an aid to bone fixation using plate and/or screw fixation principles.

The updated TriMed Total Wrist Fusion plates have minor modifications to plate length. The TriMed Total Wrist Fusion Straight Plate has an updated distal end and accepts 2.7mm screws; 2.8mm cancellous screws are included for all custom plates. The system is composed of implant-grade stainless steel components.

TriMed Total Wrist Fusion Plates were tested per FDA Guidance Document 'Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway.' TriMed Total Wrist Fusion System screws were tested per FDA Guidance Document 'Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway.' All test samples met acceptance criteria.

The device is substantially equivalent to predicate devices K102785 (TRIMED RADIOCARPAL FUSION SYSTEM) and K243999 (TriMed Ankle Fixation System) because it has the same intended use for wrist fixation, the same technological characteristics (metallic bone fixation plates and screws), and the same mechanism of action. The addition of osteotomies to indications does not constitute a material change, as an osteotomy is a controlled fracture. Testing per the same FDA guidance documents as predicates demonstrates equivalent safety and performance.