BPS - Bone Fragment Fixation Plates, Screws and Washers

The BPS - Bone Fragment Fixation Plates, Screws and Washers system is used for internal fixation of bone fractures, fusions, and osteotomies across multiple skeletal sites including the ankle, foot, hand, wrist, clavicle, scapula, pelvis, and long bones. The washers distribute forces over a larger bone surface area to prevent screw head penetration during fracture fixation of large bone and bone fragments.

The device consists of bone fixation plates, screws, and washers made from commercially pure titanium, titanium alloy (Ti6Al4V), or stainless steel. Technological characteristics including material, design, chemical composition, and principle of operation are the same as the primary and reference predicate devices, with the addition of Ti6Al4V alloy and commercially pure titanium material options.

Not stated in this summary.

The device is substantially equivalent because it has the same indications for use as the primary predicate (K130614), identical technological characteristics in design and principle of operation, and non-clinical/clinical characteristics that are the same as the predicate devices. Engineering justifications demonstrated adequate mechanical properties, and the only differences are additional material options (Ti6Al4V alloy and pure titanium) and minor modifications to screw geometry that do not alter fundamental function or safety.