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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

Zimmer Biomet Pty Ltd

Class:

Class III

Manufactured by:

Zimmer Inc 1800 W Center Street, WARSAW , INDIANA, 46580 United States Of America

Therapeutic area:

33745 - Coated knee femur prosthesis

Therapeutic indications:

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. 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. P

Authorization status:

A

Authorization date:

2014-04-22

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