Tyber Medical Distal Radius Plating System

The Tyber Medical Distal Radius Plating System is a bone fixation device consisting of various metallic plates, screws, pegs, and instruments used to treat fractures, fusions, non-unions, malunions, and osteotomies of the radius, ulna, and hand. The system includes distal radius, forearm, and fragment-specific plates manufactured from stainless steel, titanium alloy, or commercially pure titanium, available in both sterile and non-sterile formats.

The subject device has identical technological characteristics to the predicate devices, including the same design, material, chemical composition, and principle of operation. The additional plates, screws, pegs, and instrumentation utilize similar materials to previously cleared predicate devices. Engineering analysis demonstrates the new plate designs have improved resistance to bending due to higher moment of inertia.

Mechanical testing was performed in conformance with the FDA currently-recognized version of ASTM F543 for metallic bone screws, evaluating torsional strength, driving torque, and axial pullout. No clinical testing was performed.

This submission is a line extension to a previously cleared device (K232693) that includes additional plates, screws, pegs, cases, trays, and instrumentation. Since the new components share identical indications for use and technological characteristics with the predicates, and mechanical testing demonstrates equivalent or superior performance to predicate devices, substantial equivalence is established. The device's design variations provide improved mechanical properties without changing the fundamental fixation principle or clinical application.