Device Dossier

MUTARS proximal ulna silver - Hinged total elbow prosthesis

Device Dossier for MUTARS proximal ulna 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 proximal ulna as part of a hinged elbow. 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. Contains the corresponding wear pairing of the hinged MUTARS distal humerus joint replacment. Bushings made of CoCrMo are pressed into the ulna component for coupling with the distal humerus via the axle. The proximal ulna is an all extraosseous part. The bushings have a length of 14.8 mm. The inner diameter is 8 mm and the outer diameter is 11 mm. The proximal ulna component is proximally sandblasted and distally high polished.

TGA Public Summary