Device Dossier

2M Implacross E head - Constrained polyethylene acetabular liner

Device Dossier for 2M Implacross E head - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner, Class III, sponsor Life…

Intended purpose

The 2M Implacross E dual mobility head is intended to be used with the EcoFit 2M cup and a femoral head as part of dual mobility total hip replacement. Total hip replacement with the EcoFit 2M hip system applies to the following indications: - Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - Post-traumatic osteoarthritis, - Fractures, - Rheumatoid arthritis, - Acquired or congenital dysplastic disorders of the hip with increased risk of dislocation and instability, - After complications such as dislocation revision surgery is required, leaving the existing stem in place and reducing the risk of dislocation, - Revision.

Functional description

The 2M Implacross E head is made of implacross E (crosslinked polyethylene with vitamin E). The heads are snapped on a regular femoral head as part of the EcoFit 2M system. Through this combination the system allows a combined articulating of two bearings; between an ic-head and the inner surface of the 2M implacross E head and the outer surface of the 2M implacross E head and the inner surface of a EcoFit 2M Cup.

TGA Public Summary