Device Dossier

balanSys REVISION PE Inlay - Bicompartmental knee prosthesis

Device Dossier for balanSys REVISION PE Inlay - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis Surgical).…

Intended purpose

The balanSys REVISION PE Inlay 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 PE Inlay with stabilisation screw 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