Device Dossier

MUTARS connecting part silver - Body femoral/tibial extension stem, uncoated

Device Dossier for MUTARS connecting part silver - Body femoral/tibial extension stem, uncoated (Body femoral/tibial extension stem, uncoated, Class III,…

Intended purpose

A component of the MUTARS system intended to be sued as an extraosseous length adjustment in the area of the distal femur or proximal tibia for the bridging of bone defects. 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 anti-infective coating. Consists of two parts: the MUTARS connecting part distal & MUTARS connecting part proximal. The two parts are connected to each other with the MUTARS screw for connecting part. Utilizes the MUTARS cylindrical fit & serration connection design for attachment to the distal femur or modular proximal tibia component and a femoral or tibial stem. The connecting part has 1 retention ring for securing a PET mesh soft tissue attachment tube.

TGA Public Summary