Device Dossier

balanSys RP Tibial Plateau Cemented - Bicompartmental knee prosthesis

Device Dossier for balanSys RP Tibial Plateau Cemented - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis…

Intended purpose

A mobile bearing cemented tibial component which is part of the balanSys knee system, which enables anatomical knee replacement and the treatment of degenerative or post-traumatic arthrosis, failed surface replacement (e.g. infection, loosening etc), fracture or avascular necrosis of the knee joint, correction of varus, valgus or flexion malpositioning and rheumatoid arthritis.

Functional description

A mobile bearing cemented tibial component that forms part of the balanSys knee system that is designed specifically to enable maximum motion, reinstatement of the normal alignment of the leg and stable fixation of the component.

TGA Public Summary