Device Dossier

Orthopaedic fixation plate, non-biodegradable

Device Dossier for Orthopaedic fixation plate, non-biodegradable (Orthopaedic fixation plate, non-biodegradable, Class IIb, sponsor Integrant). ARTG…

Intended purpose

The Ankle Fusion Plate and Screw set is used to fuse the ankle joint using a anatomically contoured plate and 6 screws. The plate is fixed to the Tibia and Talus with screws and a Home Run Screw is used to fuses the Talus and Calcaneus together. The design of the plate allows for the screws to be placed in a range of positions and in particular and hole for the Home Run Screw allows for the screw to be inserted at a range of angles to facilitate the best fusion for each particular case. The Ankle Fusion Set contains one titanium plate and 63 titanium screws of various diameters and lengths to allow for the best fusion for each particular case.

TGA Public Summary