Device Dossier

MUTARS connecting part for diaphyseal implant silver - Diaphysis prosthesis

Device Dossier for MUTARS connecting part for diaphyseal implant silver - Diaphysis prosthesis (Diaphysis prosthesis, Class III, sponsor Life…

Intended purpose

A connecting part for a diaphyseal implant to bridge diaphyseal bone defects of the femoral bone with a silver coating to prevent infection and colonisation of the implant. 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 TiAl6V4 with silver anti-infective coating. A component of the MUTARS (Modular Universal Tumor and Revision) System. Connects between the MUTARS Diaphyseal implant and an extension piece or directly to a femoral stem.

TGA Public Summary