Device Dossier
PERSONA™, The Personalized Knee System, Femur, Cemented, Cruciate Retaining (CR) - Uncoated knee femur prosthesis
Device Dossier for PERSONA™, The Personalized Knee System, Femur, Cemented, Cruciate Retaining (CR) - Uncoated knee femur prosthesis (Uncoated knee femur…
- GMDN category: Uncoated knee femur prosthesis
Intended purpose
The Cruciate Retaining (CR) Femur is a component of Persona™, The Personalized Knee System which is a semiconstrained total knee prosthesis. This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Functional description
The Cruciate Retaining (CR) femoral component is made from Zimaloy® Cobalt-Chrome-Molybdenum alloy. The CR Femur can be used with CR articular surfaces when a functional posterior cruciate ligament exists or with a UC articular surface when both cruciate ligaments are excised. Active flexion ranges from 145-155 degrees depending on the articular surface component used. The narrow components have a smaller ML aspect ratio. Intended for cemented use only.