TMC Compression Implant System

The TMC Compression Implant System is a bone fixation device comprised of titanium staple implants and associated surgical instruments. It is intended for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle, with staples offered in multiple configurations (2-legged, 4-legged, and cannulated versions) and locking screws for additional fixation.

The device is manufactured from implant-grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 with Type II anodization, identical to the predicate. Key modifications include introduction of two additional tine staple designs with updates to bridge geometry, tine diameter, and tine length, while the 4x1 staple design remains unchanged. All components are sterilized by gamma irradiation.

Mechanical testing and analysis per ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples, specifically four-point bending tests (Annex A1) and pull-out strength testing (Annex A2).

The subject device shares identical material composition (Ti-6Al-4V-ELI with Type II anodization), identical intended use, and similar overall geometry and construction to the predicate TMC Compression Implant System. The modifications (new tine staple designs with geometry and diameter updates) do not change the fundamental fixation mechanism or clinical application. Mechanical testing demonstrated the new designs meet all acceptance criteria and perform equivalently to the predicate devices in fatigue strength and pull-out strength.