Device Dossier

EP-FIT PLUS BIOLOX Delta Ceramic Insert - Ceramic acetabular liner

Device Dossier for EP-FIT PLUS BIOLOX Delta Ceramic Insert - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Smith & Nephew). ARTG…

Intended purpose

An acetabular component of the EP-FIT PLUS Press-Fit cup system. The EP-FIT PLUS BIOLOX Delta Ceramic Insert 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 ceramic (Al203 ZrO2) acetabular insert to be used in combination with a ceramic ball head. Following trialling with a trial head the insert may be placed into the acetabular shell by hand or with the insert positioning instrument. The alignment guide should be used to aid with positioning. Positioning can be verified by making sure the shell and insert sit flush, and the insert is fixed into place using the inserter/impactor.

TGA Public Summary