Device Dossier

PERSONA, The Personalized Knee System, Femur, Trabecular Metal, Cruciate Retaining (CR), Porous - Coated knee femur prosthesis

Device Dossier for PERSONA, The Personalized Knee System, Femur, Trabecular Metal, Cruciate Retaining (CR), Porous - Coated knee femur prosthesis (Coated…

Intended purpose

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. Porous coated components may be used cemented or uncemented (biological fixation).

Functional description

The device is porous coated and made from Zimaloy Cobalt-Chrome-Molybdenum alloy, titanium, and Trabecular Metal material. They are designed for articulation with a CR articular surface component to provide a maximum active flexion of 155°, or with an Ultra-Congruent(UC) articular surface component to accommodate a maximum active flexion of 145°. The CR femur is for use with CR articular surfaces when a functional posterior cruciate ligament exists.

TGA Public Summary