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The Biomet Forerunner™ Plating System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones. This 510(k) expands the indications for use to the forefoot, and adds specific indications for midfoot/forefoot procedures: 1. Treatment of fractures and fracture-dislocations of the midfoot/forefoot 2. Malunions 3. Non-unions 4. Joint fusions/arthrodesis 5. Corrective osteotomies for deformities These procedures in the midfoot/forefoot may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Biomet Forerunner" Plating System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from Ti-6Al-4V.

The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius. In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Single/multiple metallic bone fixation appliances and accessories (21 CFR 888.3030)

The OptiLock® VL Distal Radius Plating System consists of a series of plates, screws and locking pegs that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include: 1. Fixation of intra-articular and extra-articular fractures 2. Treatment of mal-unions 3. Treatment of non-unions 4. Osteotomies 5. Wrist arthrodesis

The OptiLock® VL Distal Radius Plating System is comprised of a series of anatomically contoured plates, and locking, variable angle locking and non-locking screws, as well as locking pegs intended to be used in the distal radius, ulna (and other small bones). This system may also be used in osteopenic bone. The plates are available in several styles to address the anatomy of the distal radius/ulna. The screws are available in two diameters, in locking, non-locking and variable angle locking styles. Locking pegs are also available as an option for stabilizing the plate to the bone. The plates and screws of the OptiLock® VL Distal Radius Plating System are fabricated from titanium alloy (Ti-6Al-4V), which conforms to ASTM specification F-136, or stainless steel alloy which conforms to ASTM specification F-138 or F-139. Plates and screws fabricated from titanium alloy are anodized to color-code the different sizes to assist the surgeon with size selection.