Device Dossier

MUTARS distal femur M-O-M TiN/silver - Uncoated knee femur prosthesis

Device Dossier for MUTARS distal femur M-O-M TiN/silver - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Life…

Intended purpose

A component of the MUTARS system intended to replace the entire distal femur. 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 CoCrMo with silver coating & TiN coating. Articulates with a tibial bearing insert attached to a tibial plateau or proximal tibia. Includes section that replaces the bone of the distal femoral shaft. Designed with medial & lateral voids filled with TiAl6V4 metal plugs. 5° tilt between rotation & femoral axis to match anatomical characteristics. Uses cylindrical fit connection for attachment of a femoral stem retention ring for fixation of a PET mesh soft tissue attachment tube.

TGA Public Summary