Device Dossier

Orthopaedic fixation plate, non-biodegradable

Device Dossier for Orthopaedic fixation plate, non-biodegradable (Orthopaedic fixation plate, non-biodegradable, Class IIb, sponsor Advita Ortho AUS).…

Intended purpose

The devices are non-bioabsorbable, non-customised, implantable orthopaedic fixation plates intended to be used for bone fixation to facilitate healing. The devices are specifically indicated for fracture fixation, bone reconstruction of the foot and ankle, arthrodesis of the first metatarsophalangeal (MTP) joint, including fixation of the distal lateral fibula, distal posterior tibia, distal posterolateral fibula, and medial malleolus. The devices are intended to be affixed to bone using compatible orthopaedic screws and may be used in conjunction with additional fixation implants where required.

TGA Public Summary