Device Dossier

balanSys UC PE inlay fixed - Bicompartmental knee prosthesis

Device Dossier for balanSys UC PE inlay fixed - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis Surgical).…

Intended purpose

An ultra-congruent polyethylene fixed insert 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 balanSys UC PE Inlay features a unique cup model design. Manufactured with a high frequency machining process the PE Inlay offers an extraordinary smooth articular surface resulting in a lower potential for polyethylene wear and delamination. The inlay is securely fixed with the 4 point fixation system of the tibia plateau. The strong interface restricts any movement of the two implants completely and virtually eliminates backside wear of the PE inlay.

TGA Public Summary