Device Dossier

Implacross PE insert 15 degree . - Constrained polyethylene acetabular liner

Device Dossier for Implacross PE insert 15 degree . - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner, Class III,…

Intended purpose

A polyethylene cup insert used with cementless acetabular reconstruction cup as part of a revision or oncological procedure. Implant is used with the MUTARS RS Cup and Lumic Cup. Primary indication for the use of the MUTARS systems is after bone resection because of a tumour. Further indications for the use of the MUTARS systems are massive bone loss such as in Morbus Gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis, arthrosis, and large cavitary or segmental acetabular defects.

Functional description

Crosslinked UHMWPE insert for use with the RS and Lumic cups. The liners are available with a 15° lateral lip version (0mm and 4mm offset) to provide greater coverage of the femoral head to help prevent dislocation in cases at greater risk of dislocation, such as hip dysplasia. The PE inserts with 4mm allow for an adjustment of the rotation center after implantation.

TGA Public Summary