PFC Sigma Modular Tibial Tray - CoCr - Prosthesis, internal, joint, knee, tibial component - Uncoated knee tibia prosthesis, metallic

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
01-12-2017

제공처:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

수업:

Class III

Manufactured by:

Depuy Orthopaedics Inc 700 Orthopaedic Drive, Warsaw, IN, 46582 United States Of America

치료 영역:

32832 - Uncoated knee tibia prosthesis, metallic

치료 징후:

The PFC Sigma Modular Tibial Tray - CoCr is designed to replace the tibial condyles during bicondylar replacement of the knee joint and is made of CoCr with a highly polished top surface. The i2 locking mechanism locks in the tibial insert which decreases micro-motion. Implantation is intended to be performed with bone cement. The PFC Sigma Modular Tibial Tray - CoCr is the tibial resurfacing component which holds the insert component of a total knee arthroplasty. It is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

승인 상태:

A

승인 날짜:

2014-08-22

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