Device Dossier

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

Device Dossier for PERSONA™, The Personalized Knee System, Vivacit-E® HXPE Articular Surface, Fixed Bearing, Ultracongruent (UC) - Prosthesis, knee,…

Intended purpose

The Vivacit-E® Highly Crosslinked Polyethylene (VEHXPE) Posterior Stabilized (PS) Ultracongruent (UC) Articular Surface is a component of the 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) Ultracongruent (UC) Articular Surface is a component of the Persona™, The Personalized Knee System which is a semiconstrained total knee prosthesis. It is made from Vitamin-E stabilized highly crosslinked polyethylene, and is used with a CR femur when both cruciate ligaments are excised and additional anterior constraint is needed.

TGA Public Summary