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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Smith & Nephew Pty Ltd

Klasse:

Class III

Fremstillet af:

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

Terapeutisk område:

43168 - Non-constrained polyethylene acetabular liner

Terapeutiske indikationer:

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

Autorisation status:

A

Autorisation dato:

2014-04-16