TDM Plate and Screw System

The TDM Plate and Screw System is a family of titanium alloy or pure titanium plates and screws designed for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions. The Mini and Mid Locking systems are intended for hand, wrist, and small foot bones, while the Small Locking system is indicated for clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The device consists of flat and contoured locking plates constructed from Ti-6AL-4V alloy or pure titanium, paired with locking and non-locking screws (1.5mm to 4.0mm diameter, 6mm to 100mm length) that are threaded, cortical, cancellous, or cannulated. The technological characteristics are equivalent to the predicate devices in design, material composition, function, size range, and packaging.

Performance testing was conducted in accordance with ASTM F543-17 (Static 4-Point Bending) and ASTM F1264-16 (Axial Pullout and Torsional testing) to demonstrate mechanical performance equivalence.

The device demonstrates substantial equivalence through identical material composition (titanium alloys), equivalent mechanical performance across static and dynamic loading tests, and matching intended uses and anatomical applications as its predicate devices (K190391 and K171808). The nonclinical testing data shows the subject device performs as safely and effectively as the predicates across all tested mechanical parameters.