Device Dossier

PERSONA™, The Personalized Knee System, Vivacit-E® HXPE Articular Surface, Fixed Bearing, Posterior Stabilized (PS) - Prosthesis, knee, internal, insert component

Device Dossier for PERSONA™, The Personalized Knee System, Vivacit-E® HXPE Articular Surface, Fixed Bearing, Posterior Stabilized (PS) - Prosthesis,…

Intended purpose

The Vivacit-E® Highly Crosslinked Polyethylene (VEHXPE), Posterior Stabilized (PS) 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 (VEHXPE), Posterior Stabilized (PS) articular surface is a component of Persona™, The Personalized Knee System, which is a semiconstrained total knee prosthesis. The articular surface component is composed of Vitamin-E stabilized highly crosslinked polyethylene. It is used with a PS Femur when both cruciate ligaments are excised.

TGA Public Summary