Device Category Dossier

External orthopaedic fixation system, single-use

Device Category Dossier for External orthopaedic fixation system, single-use. Australian ARTG records, sponsors, device class — compiled by arcimedes.

External temporary fixators are single-use devices composed of bone screws, clamps, rods and accessories that are assembled into a fixator construct to aid in temporary fixation of bone fractures. These devices are used to stabilise long bones including the femur, tibia and humerus, as well as pelvic fractures, and are indicated for open or closed fractures, non-unions, arthrodesis, osteotomies with associated soft tissue problems, and limb stabilisation following joint arthroplasty.