Device Dossier

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

Device Dossier for EP-FIT PLUS Shell Ti-Plasma/HA - Acetabular shell (Acetabular shell, Class III, sponsor Smith & Nephew). ARTG record, intended…

Intended purpose

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

Functional description

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.

TGA Public Summary