Device Dossier

MUTARS Distal Femur M-O-M TiN - Uncoated knee femur prosthesis

Device Dossier for MUTARS Distal Femur M-O-M TiN - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Life Healthcare).…

Intended purpose

A component of the MUTARS system intended to replace the distal extra-articular femoral section of the knee. 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

Constructed from CoCrMo alloy with titanium nitride coated to prevent allergic reactions. M-O-M components are coupled by the metal-on-metal connecting mechanism. It is recommended to use the M-O-M components in case of an extra-articular resection. Connects to various femoral stems and extension pieces as part of a Modular Universal Tumor and Revision System (MUTARS).

TGA Public Summary