Device Dossier
PERSONA™, The Personalized Knee System, Vivacit-E® HXLPE Articular Surface, Fixed Bearing, Cruciate Retaining (CR) - Prosthesis, knee, internal, insert component
Device Dossier for PERSONA™, The Personalized Knee System, Vivacit-E® HXLPE Articular Surface, Fixed Bearing, Cruciate Retaining (CR) - Prosthesis, knee,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The Cruciate Retaining (CR) 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
The Vivacit-E® Highly Crosslinked Polyethylene Cruciate Retaining Articular Surface is a component of Persona™, The Personalized Knee System which is a semiconstrained total knee prosthesis. It is made from Vitamin-E stabilized highly crosslinked polyethylene. CR articular surfaces are to be used with a CR femur when a functional PCL exists.