Device Dossier

MUTARS distal humerus silver - Hinged total elbow prosthesis

Device Dossier for MUTARS distal humerus silver - Hinged total elbow prosthesis (Hinged total elbow prosthesis, Class III, sponsor Life Healthcare). ARTG…

Intended purpose

A component of the MUTARS system intended to replace the distal part of the humerus. 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. Consists of 3 parts: the distal humerus component, CoCrMo distal humerus bushing and axle. The bushings are laterally pressed into the distal humerus and the bushings serve as the articulating component for the hinge mechanism (axle). The distal humerus is an all extraosseous part. Uses cylindrical fit and serration connection for attachment to various components. Has a retention ring for securing a PET mesh soft tissue attachment tube component.

TGA Public Summary