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

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Download Laporan Penilaian Awam (PAR)
09-11-2017

Boleh didapati daripada:

Smith & Nephew Pty Ltd

Kelas:

Class III

Dikeluarkan oleh:

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

Kawasan terapeutik:

43168 - Non-constrained polyethylene acetabular liner

Tanda-tanda terapeutik:

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

Status kebenaran:

A

Tarikh kebenaran:

2014-04-16

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