EP-FIT PLUS REXPOL Insert Standard - Acetabulum prosthesis - Non-constrained polyethylene acetabular liner

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Smith & Nephew Pty Ltd

Classe:

Class III

Prodotto da:

Smith & Nephew Orthopaedics AG Oberneuhofstrasse 10d, Baar, 6340 Switzerland

Area terapeutica:

43168 - Non-constrained polyethylene acetabular liner

Indicazioni terapeutiche:

A sterile non-cemented REXPOL (highly cross-linked polyethylene) acetabular insert. The ideal insert to be used with the acetabular shell is determined by using insert trials. Following trialing, the REXPOL insert is impacted using an inserter/impactor or if a 36mm insert is used, it should be placed manually or with the insert positioning instrument. The primary seating of the REXPOL insert may be checked using a rasp. An acetabular component of the EP-FIT PLUS Press-fit cup system. The EP-FIT PLUS REXPOL Insert Standard is intended to be used for the following indications: ? All forms of arthritis ? Progressive loss of function of the hip joint as a result of degenerative posttraumatic or inflammatory/rheumatic destruction of the joint ? Femoral head necrosis ? Fractures in the region of the femoral neck or hip joint ? Status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint replacement

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2014-04-16