NexGen? Complete Knee Solution, Fluted Stemmed Tibial Component, Option - Uncoated knee tibia prosthesis, metallic

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
09-11-2017

可用日期:

Zimmer Biomet Pty Ltd

类:

Class III

厂商:

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

治疗领域:

32832 - Uncoated knee tibia prosthesis, metallic

疗效迹象:

Fluted stemmed plate tibial component of the NexGen semiconstrained, nonlinked condylar knee System. It is designed to be cemented not only on the proximal surface of the tibal, but around the keel of the plate as well. It is made from Tivanium Ti-6Al-4V Alloy and is for cemented use. Fluted stemmed plate tibial component of the NexGen semiconstrained, nonlinked condylar knee prosthesis system 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.

授权状态:

A

授权日期:

2014-02-12

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