Device Dossier

balanSys vitamys RP Inlay - Bicompartmental knee prosthesis

Device Dossier for balanSys vitamys RP Inlay - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis Surgical).…

Intended purpose

The balanSys Bicondylar prosthesis is intended for treating degenerative joint diseases of the knee joint in skeletally mature patients. Indications include: - Painful and / or disabling joint disease of the knee resulting from osteoarthritis, avascular necrosis, inflammatory arthritis or post-traumatic arthritis - Revision of previous knee replacement - Fracture of the distal femur and / or proximal tibia that cannot be stabilized by standard fracture management techniques

Functional description

The balanSys vitamys RP Inlay is a mobile bearing insert that features a unique cup model design. Manufactured with a high frequency machining process the vitmays inlay offers an extraordinary smooth articular surface resulting in a lower potential for polyethylene wear and delamination.

TGA Public Summary