METS SMILES Knee, Tibial fixed hinge assembly - Uncoated knee tibia prosthesis, metallic

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
04-11-2017

Dostopno od:

Stryker Australia Pty Ltd

Razred:

Class III

Izdeluje:

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

Terapevtsko območje:

32832 - Uncoated knee tibia prosthesis, metallic

Terapevtske indikacije:

The SMILES Fixed Hinge assembly is a Co-Cr-Mo tibial component. Stem lengths 140 and 180mm and 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 fixed hinge 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 ? The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue.

Status dovoljenje:

A

Datum dovoljenje:

2016-07-23

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