Device Dossier

MUTARS diaphyseal implant silver - Diaphysis prosthesis

Device Dossier for MUTARS diaphyseal implant silver - Diaphysis prosthesis (Diaphysis prosthesis, Class III, sponsor Life Healthcare). ARTG record,…

Intended purpose

A component of the MUTARS system intended to bridge diaphyseal bone defects of the femoral bone. 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. The silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.

Functional description

Composed of CoCrMo alloy. The surface is sandblasted and provides a silver coating which is applied circumferentially on the extra osseous part of the component. It is to be combined with the MUTARS Connecting Part for Diaphyseal Implant. The two parts are attached to each other by the means of the MUTARS Screws for Diaphyseal Implant and can be combined with femoral stems & extension pieces depending on the size & position of the resection required.

TGA Public Summary