PFC Sigma Modular Plus Tibial Tray - 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)
01-12-2017

可用日期:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

类:

Class III

厂商:

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

治疗领域:

32832 - Uncoated knee tibia prosthesis, metallic

疗效迹象:

The PFC Sigma Modular Plus Tibial Tray is made of a titanium alloy and is intended for cemented use during revision or primary total knee arthroplasty. The modular stem attachment of the offset variant is offset medially from the centre of the plateau which provides optimal proximal tibial plateau coverage while also facilitating proper stem placement in the intramedullary canal. The PFC Sigma Modular Plus Tibial Tray is the tibial 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, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

授权状态:

A

授权日期:

2014-03-28

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