Meniscal Insert - Ultracongruent - Prosthesis, knee, internal, insert component

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)
10-11-2017

可用日期:

Allegra Orthopaedics Limited

类:

Class III

厂商:

Allegra Orthopaedics Limited Unit 2 / 12 Frederick Street, ST LEONARDS, NSW, 2065 Australia

治疗领域:

46585 - Prosthesis, knee, internal, insert component

疗效迹象:

A polyethylene liner component designed to provide the articulating bearing surface between the femoral and tibial components of a total knee replacement. The Ultracongruent is designed with an anterior lip for additional posterior stability. The meniscal ultracongruent insert implant is a component of the Active Knee System. The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support prosthesis. It is intended for Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Functional deformity such as varus, valgus or flexion deformities; Revision procedures where other treatments or devices have failed; Fractures that are unmanageable using other techniques.

授权状态:

A

授权日期:

2013-11-14

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