Device Dossier

UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Uncoated unicondylar knee tibia prosthesis, polyethylene

Device Dossier for UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Uncoated unicondylar knee tibia prosthesis, polyethylene (Uncoated unicondylar knee tibia…

Intended purpose

A modular unicondylar knee that replaces the bearing surfaces of one femoral condyle and the corresponding tibial condyle, to achieve reconstruction replacement of the deficient knee component. Indication: Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis. Revision of previous unsuccessful unicompartmental knee replacement or other procedure. As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

Functional description

A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and articulates with an artificial Femoral Component on the corresponding condyle. A component of the Unix unicompartmental Knee System intended to replace the bearing surface of one tibial condyle (medial or lateral condyle) of the knee joint. made of polyethylene (UHWMPE).

TGA Public Summary