Device Category Dossier

Orthopaedic external fixation system, single-use, sterile

Device Category Dossier for Orthopaedic external fixation system, single-use, sterile. Australian ARTG records, sponsors, device class — compiled by…

External fixation systems are sterile assemblies of devices used to stabilise fractured bones to promote treatment and healing , with components including rings, posts, plates, hinges, distraction elements, struts and threaded rods that keep bone segments aligned during the healing process . These systems are used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening , and are also intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities .