Device Dossier

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

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

Intended purpose

The Medial Congruent Articular Surface is a component of the Persona Personalized Knee System, and 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

A medial congruent articular surface may be used with a CR femur when a functional PCL is present or absent. Made from Vitamin-E stabilized highly crosslinked polyethylene (VEHXPE).

TGA Public Summary