TRIDENT ELEVATED RIM X3 ACETABULAR INSERT - Non-constrained polyethylene acetabular liner

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:

Stryker Australia Pty Ltd

类:

Class III

厂商:

Howmedica Osteonics Corporation 325 Corporate Drive, Mahwah, New Jersey, 07430 United States Of America

治疗领域:

43168 - Non-constrained polyethylene acetabular liner

疗效迹象:

This Acetabular Insert is the inner portion of a two-piece acetabulum prosthesis that is sterile and made of X3 polyethylene (highly cross-linked UHWMPE). Inserted into an Acetabular Shell, to articulate with an artificial Femoral Head as part of a Total Hip Arthroplasty (THA). The insert allows rotational alignment using 12 indexable scallops. Four alignment studs on the shell provide rotational and axial alignment. 3mm superior polyethylene lip. A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. Indications ? Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. ? Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ? Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. ? Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

授权状态:

A

授权日期:

2014-02-24

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