Device Dossier

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

Device Dossier for EP-FIT PLUS REXPOL Insert Standard - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner,…

Intended purpose

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

Functional description

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.

TGA Public Summary