Device Dossier
PERSONA™, The Personalized Knee System, Vivacit-E® HXPE Articular Surface, Fixed Bearing, Constrained Posterior Stabilized (CPS) - Prosthesis, knee, internal, insert component
Device Dossier for PERSONA™, The Personalized Knee System, Vivacit-E® HXPE Articular Surface, Fixed Bearing, Constrained Posterior Stabilized (CPS) -…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The Constrained Posterior Stabilized (CPS), Vivacit-E® Highly Crosslinked Polyethylene (VEHXPE) Articular Surface 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
Made from Vitamin-E stabilized highly crosslinked polyethylene the CPS Articular Surface is a component of Persona™, The Personalized Knee System, a semiconstrained total knee prosthesis. It is used with a Posterior Stabilized (PS) femur when both cruciate ligaments are excised, moderate varus/valgus constraint is needed & stems & augments are not required. CPS articulating surfaces are for use with cemented non-porous tibial and femoral components