Device Dossier

MUTARS humerus reducer silver - Humeral stem extension prosthesis

Device Dossier for MUTARS humerus reducer silver - Humeral stem extension prosthesis (Humeral stem extension prosthesis, Class III, sponsor Life…

Intended purpose

A component of the MUTARS system intended to provide extraosseous length adjustment in cases of a total humerus 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. 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 coating. Combines the MUTARS humerus connection part with the MUTARS Humerus Extension Piece or MUTARS Humerus Head with the MUTARS Distal Humerus. The reducer utilizes the MUTARS cylindrical fit and serration connection design for attachment to the MUTARS Humerus Head, Humerus Extension Piece, Humerus Connecting Part, Humerus Stem, Distal Humerus, Proximal Ulna.

TGA Public Summary