Treace Medical Concepts (TMC) Screw Fixation System

The TMC Screw Fixation System is a bone fixation device consisting of headed and headless, cannulated and non-cannulated screws manufactured from titanium alloy (Ti6Al4V-ELI). It is intended for primary and revision fracture fixation, joint fusions, bone reconstructions, osteotomies, pseudoarthroses, and ligament fixation in adult and pediatric patients over 12 years of age at multiple anatomical sites including the upper and lower extremities.

The subject device shares identical materials and similar geometry, construction, and overall design with the predicate system. Technological differences include geometric modifications to the screws. The device maintains the same titanium alloy composition, sterile gamma irradiation sterilization, and intended uses as predicate devices.

ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws; ISO 11137-1 and -2 for sterilization validation; ISO 11607-1 and -2 for packaging validation. Testing evaluated torsional strength, driving and removal torque, and axial pullout strength.

The subject device is substantially equivalent because it shares identical materials, similar geometry, construction, and overall design with predicate devices. Technological differences are limited to geometric modifications that do not raise new questions of safety and effectiveness. The device met all performance criteria specified in FDA guidance and demonstrated equivalent performance to predicate screws through mechanical testing and biocompatibility evaluation leveraging material and manufacturing equivalence.