Device Dossier

balanSys REVISION Tibial Plateau Cemented - Bicompartmental knee prosthesis

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

Intended purpose

The balanSys REVISION cemented tibial plateau forms part of the balanSys REVISION knee system that enables anatomical knee replacement and the treatment of difficult cases such as arthrosis and joint instabilities.

Functional description

The balanSys REVISION Tibial Plateau is a cemented tibial component that forms part of the balanSys REVISION System that is designed to restore and reconstruct failed total knee arthroplasty. The system will enable the restoration of correct limb alignment, the restoration of knee biomechanics and balanced medial/ lateral and flexion/extension gaps. It is designed specifically to enable maximum motion, reinstatement of the normal alignment of the leg and stable fixation of the component.

TGA Public Summary