PERSONA, The Personalized Knee System, Natural Tibia, Trabecular Metal, Two-Peg, Porous, Fixed Bearing - Coated knee tibia prosthesis

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Zimmer Biomet Pty Ltd

class:

Class III

manufactured_by:

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

therapeutic_area:

34198 - Coated knee tibia prosthesis

therapeutic_indication:

Porous tibial components of the Persona, The Personalized Knee System, semiconstrained total knee prosthesis designed to replace the proximal portion of the tibia. Tibial components are made from Tivanium Ti-6AI-4V alloy and Trabecular Metal material. The asymmetric tibial component is available in left and right configurations with multiple Medial/Lateral sizes. 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).

authorization_status:

A

authorization_date:

2014-04-11