Device Dossier

Fixation plate, fracture-healing, non-biodegradable.

Device Dossier for Fixation plate, fracture-healing, non-biodegradable. (Fixation plate, fracture-healing, non-biodegradable., Class IIb, sponsor…

Intended purpose

Locking Plate System indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. 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. Tibial plates indicated for fractures, osteotomies, and non-unions of the pediatric and small adult tibia.

TGA Public Summary