Device Dossier

Orthopaedic bone washer, non-sterile

Device Dossier for Orthopaedic bone washer, non-sterile (Orthopaedic bone washer, non-sterile, Class IIb, sponsor Actis Medical). ARTG record, intended…

Intended purpose

The washers included in the screw system and plating system are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation of the foot and ankle, including the tibia, fibula, tarsus, metatarsals, and phalanges and the joints and ligaments coupling said bones, appropriate for the size of the device. They are also indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, distal fibula, talus, and calcaneus.

TGA Public Summary