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

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
09-11-2017

제공처:

Medacta Australia Pty Ltd

수업:

Class III

Manufactured by:

Medacta International SA Strada Regina 6874 Castel, San Pietro Switzerland

치료 영역:

33580 - Uncoated knee tibia prosthesis, polyethylene

치료 징후:

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.

승인 상태:

A

승인 날짜:

2014-04-11

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