BPS Wrist Fracture System

The BPS Wrist Fracture System is a bone plate and screw fixation device designed to treat simple and complex fractures of the distal radius in adults, including specific fracture types (AO types A2, A3, B1, B3, C1, C2, C3) and osteotomies. The plates are manufactured from Commercially Pure Titanium Grade 4, and the screws from Titanium Alloy Grade 5.

The subject device has the same technological characteristics as the predicate devices, including identical indications for use, principle of operation, design, and materials. Compared to the K242343 predicate, the subject device features a wider proximal portion at the carpal side of the plates, which is a geometric modification rather than a fundamental design change.

Not stated in this summary. The document references non-clinical performance testing including cleaning, sterilization, biocompatibility, mechanical and performance characteristics, but does not cite specific ISO, IEC, or ASTM standards.

The device is substantially equivalent because it shares the same indications for use, anatomical site, materials of manufacture, plate sizes, and screw styles and sizes as the predicates. The only difference—a wider proximal portion at the carpal side—is a geometric refinement within the same functional category. Non-clinical testing demonstrated substantial equivalence in cleaning, sterilization, biocompatibility, and mechanical performance characteristics to the predicate devices.