Device Dossier
balanSys PS PE inlay fixed - Bicompartmental knee prosthesis
Device Dossier for balanSys PS PE inlay fixed - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis Surgical).…
- GMDN category: Bicompartmental knee prosthesis
Intended purpose
A posterior stabilised 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 PS 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.