GMK Primary Fixed Tibial Insert STD - Uncoated knee tibia prosthesis, polyethylene

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:

Medacta Australia Pty Ltd

类:

Class III

厂商:

Medacta International SA Strada Regina 6874 Castel, San Pietro Switzerland

治疗领域:

33580 - Uncoated knee tibia prosthesis, polyethylene

疗效迹象:

The GMK Primary Standard Fixed Tibial Insert is manufactured from UHMWPE and is designed to be used with the GMK Primary femoral and fixed tibial components. The inlay clipping mechanism assures time-effective and safe implantation. GMK Standard Fixed Tibial Insert forms part of the GMK Primary Knee System that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

授权状态:

A

授权日期:

2014-04-11

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