TriMed Ankle Fixation System

The TriMed Ankle Fixation System is a comprehensive surgical implant system for treating ankle fractures, non-unions, and osteotomies of the distal tibia and fibula. It consists of metallic plates, screws, and wire devices made from 316L stainless steel, designed to stabilize fractured bone surfaces during healing.

The device shares the same basic design features, intended use, and fundamental scientific technology as the predicate devices. It consists of metallic plates and screws in various configurations (Sidewinder, Cluster, Straight, Ankle Hook plates, and Medial Malleolar Sleds) to accommodate different patient anatomies and fracture types. Any differences from the predicate are considered minor and do not raise safety or effectiveness concerns.

ASTM F543-17 (Metallic Medical Bone Screws); FDA Guidance on Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway; ASTM F382 (Metallic Bone Plates); biocompatibility and sterilization testing; static and endurance bend testing.

The TriMed Ankle Fixation System is substantially equivalent because both it and the predicate device have identical intended use, employ the same fundamental scientific principles for bone fixation, and share similar functional and technological characteristics. Mechanical performance testing demonstrates equivalent or superior performance compared to the predicate, and risk evaluation does not raise different safety or effectiveness questions.