TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)

The TriMed Volar Bearing Plates are metallic bone fixation devices made from 316L stainless steel designed to aid in the treatment of fractures, non-unions, and osteotomies of the radius. They function as an aid to fix fractured or surgically cut bone in place during the healing process using the principle of plate and screw fixation. The devices are available in three sizes (13, 14, and 16 holes) for left and right anatomical sides.

The subject device is substantially equivalent to the predicate (TriMed Wrist Fixation System 3, K222637) in terms of material composition (316L stainless steel per ASTM F138/F139), design features, principle of operation, manufacturing, packaging, and labeling. Any differences between the proposed device and predicate are considered minor and do not raise safety or effectiveness concerns.

Testing was conducted per FDA Guidance Document FDA-2022-D-0552 on Orthopedic Fracture Fixation Plates — Performance Criteria for Safety and Performance Based Pathway. The plates comply with ASTM F138/F139 material standards.

The TriMed Volar Bearing Plates are substantially equivalent to the predicate TriMed Wrist Fixation System 3 because they share identical material composition, design principles, intended use for radius fracture fixation, and manufacturing specifications. Performance testing demonstrated that the surgical instruments, caddy design, and product design do not adversely affect performance, cleanability, or sterilization, supporting substantial equivalence.