Device Dossier

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

Device Dossier for PERSONA™, The Personalized Knee System, Articular Surface, Fixed Bearing, Ultracongruent (UC) - Prosthesis, knee, internal, insert…

Intended purpose

The Ultracongruent (UC) 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 Ultracongruent (UC) Articular Surface is a component of Persona™, The Personalized Knee System which is a semiconstrained total knee prosthesis. It is composed of ultra-high molecular weight polyethylene (UHMWPE). Used with a cruciate retaining femoral component when both cruciate ligaments are excised in order to accommodate a maximum active flexion of 145°.

TGA Public Summary