CONSTRAINED ACETABULAR INSERT - Constrained polyethylene acetabular liner

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
10-11-2017

Dostopno od:

Stryker Australia Pty Ltd

Razred:

Class III

Izdeluje:

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

Terapevtsko območje:

44362 - Constrained polyethylene acetabular liner

Terapevtske indikacije:

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.

Status dovoljenje:

A

Datum dovoljenje:

2013-11-25

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