TriMed Elbow and Forearm System

The TriMed Elbow and Forearm System is a bone fixation device comprising metallic plates, wire forms, and screws used to treat fractures, malunions, and non-unions of the radius and ulna, as well as fractures and osteotomies of the olecranon. The implants provide constraint to stabilize fractured or osteotomized bone during the healing process.

The implants (plates, wireforms, washers, and cortical screws) are manufactured from 316L stainless steel. The system includes bridge plates, 2.7mm locking and non-locking screws. Minor design and packaging differences exist between the proposed device and predicate devices, but these do not raise different safety or effectiveness questions.

Static and dynamic four-point bending testing were conducted per ASTM F382-17. Testing also followed recommendations in the FDA Guidance Document on Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway.

The TriMed Elbow and Forearm System is substantially equivalent because it has the same intended use as the predicate devices (fracture fixation of the radius, ulna, and olecranon), identical material composition (316L stainless steel), and similar design principles and operation. The implants demonstrated equivalent mechanical performance through standardized testing, and minor differences in packaging and labeling do not affect safety or effectiveness.