Device Dossier
balanSys REVISION Femur Cemented - Bicompartmental knee prosthesis
Device Dossier for balanSys REVISION Femur Cemented - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis…
- GMDN category: Bicompartmental knee prosthesis
Intended purpose
The balanSys REVISION cemented femur 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 Femur is a cemented femoral 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.