Device Dossier

MUTARS humerus head - Humeral head prosthesis

Device Dossier for MUTARS humerus head - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Life Healthcare). ARTG record, intended…

Intended purpose

A component of the MUTARS system intended to replace the humeral head as part of a proximal or total humerus reconstruction. 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

Humeral head replacement prosthesis. Composed of TiAl6V4. Connects to a humerus cap and extension piece as part of a proximal or total humeral replacement in a Modular Universal Tumor and Revision System (MUTARS).

TGA Public Summary