TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)

The TriMed Fifth Metatarsal System is a bone fixation device consisting of implantable plates and screws made from implant-grade stainless steel. It is used to stabilize fractures, malunions, and non-unions of the fifth metatarsal bone in the foot.

The device is made from implant-grade stainless steel and includes both fixation plates and stand-alone screws. The subject device plates demonstrated higher peak load resistance in biomechanical testing compared to predicate devices and passed fatigue testing at 150,000 cycles. The subject screws were tested per FDA guidance on orthopedic non-spinal metallic bone screws.

Testing followed FDA Guidance Document: Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway. Subject devices underwent static cantilever loading and fatigue testing to 150,000 cycles.

The devices are substantially equivalent because they are identical in material (implant-grade stainless steel), design features, principles of operation, manufacturing, packaging, and labeling to the predicate devices. Any differences between the subject device and predicate devices are minor and do not raise different safety or effectiveness questions. Performance testing showed the subject devices meet or exceed predicate device performance, with no new safety concerns identified.