METS SMILES Knee, Tibial rotating hinge metal cased assembly - Uncoated knee tibia prosthesis, metallic

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
04-11-2017

제공처:

Stryker Australia Pty Ltd

수업:

Class III

Manufactured by:

Stanmore Implants Worldwide Ltd 210 Centennial Avenue Centennial Park, Elstree, WD6 3SJ United Kingdom

치료 영역:

32832 - Uncoated knee tibia prosthesis, metallic

치료 징후:

The SMILES Tibial rotating hinge metal cased assembly consists of a UHMWPE tibial bearing with a Co-Cr-Mo tibial component and titanium casing. Stem lengths 140 or 180mm. Knee components are available in small and standard sizes. An UHMWPE bumper available in both sizes provides a secondary bearing surface and a soft hyperextension stop, is pre-assembled within the tibial component. The Tibial rotating hinge metal cased assembly is a component of the METS Smiles Total Knee Replacement which is intended for the replacement of diseased or deficient bone around the knee joint. Indications: ? Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis ? Correction of varus, valgus or post traumatic deformity ? Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement ? Ligament deficiencies ? Tumor resections ? Revision of previously failed total joint arthroplasty ? Trauma

승인 상태:

A

승인 날짜:

2016-07-23

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