Device Dossier

balanSys Patella 3 Peg Flat - Bicompartmental knee prosthesis

Device Dossier for balanSys Patella 3 Peg Flat - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis Surgical).…

Intended purpose

A patella 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 3 pegged cemented patella is used in combination with a balanSys femoral component that has a deepened patella groove with a smooth transition from a larger radius in extension to a smaller one in flexion that reconstructs the physiological patella tracking through the full range of motion. The variable q-angle reduces the risk of patellofemoral pain or patella dislocation.

TGA Public Summary