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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Διαθέσιμο από:

Zimmer Biomet Pty Ltd

Kατηγορία:

Class III

Κατασκευάζεται από:

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

Θεραπευτική περιοχή:

33745 - Coated knee femur prosthesis

Θεραπευτικές ενδείξεις:

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

Καθεστώς αδειοδότησης:

A

Ημερομηνία της άδειας:

2014-04-22