CONSTRAINED ACETABULAR INSERT - 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)
10-11-2017

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:

44362 - Constrained polyethylene acetabular liner

疗效迹象:

Two pre-assembled components: Acetabular Insert and Femoral Head (UHR). The UHR has a factory assembled UHMWPE retention ring. The outer acetabular insert has a Ti alloy retaining ring which retains the UHR Head in the plastic portion of the insert and a CoCr alloy circumferential locking wire for secure assembly of the insert to the metal shell. The Constrained Acetabular Insert is designed to be assembled with a 50 mm or larger outer diameter Standard Profile Metal Acetabular Shell. A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. The Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

授权状态:

A

授权日期:

2013-11-25

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