Device Dossier

Orthopaedic bone screw, non-biodegradable

Device Dossier for Orthopaedic bone screw, non-biodegradable (Orthopaedic bone screw, non-bioabsorbable, sterile, Class IIb, sponsor Orthopediatrics…

Intended purpose

Cortical Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula. Large Cannulated Screws are intended for fracture fixation of large bones and large bone fragments such as femoral neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses. Small Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses.

TGA Public Summary