Treace Medical Concepts (TMC) Implant Fixation System

The TMC Implant Fixation System is a bone fixation device comprised of plates, screws, and compression implants made from titanium alloy (Ti-6Al-4V-ELI). It is intended for stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of the feet in pediatric and adult patients, with applications including osteotomies, arthrodesis, and various foot fusions.

The system includes straight, L-shaped, H-shaped, and anatomically curved plates; intramedullary plates; and cannulated and non-cannulated compression implants. Screws range from 2.5 to 3.3 mm diameter in lengths of 10–36 mm, with locking and non-locking options. All components are manufactured from implant-grade titanium alloy per ASTM F136 and are sterilized by gamma irradiation.

ASTM F382 Standard Specification and Test Method for Metallic Bone Plates (static and dynamic 4-point bend testing); FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (November 22, 2024) for axial pullout testing.

The subject device is substantially equivalent to its primary predicate (TMC Plating System K240173) and additional predicate (TMC Compression Implant System K243658) based on similar intended use, identical materials (Ti-6Al-4V-ELI per ASTM F136), equivalent packaging and sterilization methods, and comparable mechanical performance. Mechanical testing demonstrated the subject device met all acceptance criteria, confirming it does not raise new safety or effectiveness questions.