Device Dossier

balanSys PS Tibial Pl. TiNbN fix cemented - Bicompartmental knee prosthesis

Device Dossier for balanSys PS Tibial Pl. TiNbN fix cemented - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor…

Intended purpose

A posterior stabilised cemented fixed tibial component that is coated with TiNbN, 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

The posterior stabilised Tibial Plateau is a cemented tibial component that is coated with TiNbN. The tibial component has a patented 4 point fixation for the the fixed tibial insert which creates a strong interface that restricts any movement of the two implants completely and virtually eliminates backside wear of the PE inlay.

TGA Public Summary