NexGen? Complete Knee Solution, Cruciate Retaining (CR), Pegged Tibial Component, Precoat - Uncoated knee tibia prosthesis, metallic

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:

32832 - Uncoated knee tibia prosthesis, metallic

therapeutic_indication:

Cruciate ligament retaining (CR) precoated, pegged tibial component of the The NexGen? semiconstrained, nonlinked condylar knee system. It is made from Tivanium? Ti-6Al-4V alloy and indicated for cemented use only. Intended to repair or replace the tibial knee joint, 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.

authorization_status:

A

authorization_date:

2013-11-15