Device Dossier
balanSys vitamys PS Inlay - Bicompartmental knee prosthesis
Device Dossier for balanSys vitamys PS Inlay - Bicompartmental knee prosthesis (Bicompartmental knee prosthesis, Class III, sponsor Enovis Surgical).…
- GMDN category: Bicompartmental knee prosthesis
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 PS Inlay features a unique cup model design. Manufactured with a high frequency machining process the vitamys 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 vitamys inlay.