EP-FIT PLUS Shell Ti-Plasma/HA - Acetabular shell

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Boleh didapati daripada:

Smith & Nephew Pty Ltd

Kelas:

Class III

Dikeluarkan oleh:

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

Kawasan terapeutik:

43167 - Acetabular shell

Tanda-tanda terapeutik:

A sterile titanium noncontinuous spherical shell for non-cemented use only with a triple radius profile and a porous titanium plasma and hydroxyapatite coated outer surface. The cup is oversized by 2-3% in the main anchorage area to allow tight contact in the peripheral shell region and a relatively low contact in the pole region. The shell is impacted into place and additional fixation with low profile headed screws may be required in certain circumstances. An acetabular component of the EP-FIT PLUS Press-Fit cup system. The EP-FIT PLUS Shell Ti-Plasma/HA 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:

2014-05-28