Device Dossier

PERSONA™, The Personalized Knee System, Vivacit-E® Vitamin E HXPE Inset All Poly Patella, Cemented - Polyethylene patella prosthesis

Device Dossier for PERSONA™, The Personalized Knee System, Vivacit-E® Vitamin E HXPE Inset All Poly Patella, Cemented - Polyethylene patella prosthesis…

Intended purpose

The Vivacit-E® Vitamin E Highly Crosslinked Polyethylene (VEHXPE) Inset All Poly Patella 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® Vitamin E Highly Crosslinked Polyethylene (VEHXPE) Inset All Poly Patella 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 (VEHXPE) and is used to replace the natural patella (kneecap). It is designed to be used with specifically designed instrumentation that makes use of patella alignment methods and is for cemented use only.

TGA Public Summary