Device Dossier

MUTARS GenuX MK MB PE insert - Prosthesis, knee, internal, insert component

Device Dossier for MUTARS GenuX MK MB PE insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

Intended purpose

A PE insert component of the MUTARS system used as part of a knee replacement. 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 and arthrosis.

Functional description

Constructed of UHMW-PE. Mobile-Bearing PE insert component used as part of the Modular Universal Tumour and Revision System (MUTARS) in various knee replacement configurations using the GenuX MK knee revision option. The size of the PE-insert corresponds to the size of the tibial component.

TGA Public Summary