Device Dossier
MUTARS femoral spacer silver - Knee wedge
Device Dossier for MUTARS femoral spacer silver - Knee wedge (Knee wedge, Class III, sponsor Life Healthcare). ARTG record, intended purpose, GMDN…
- GMDN category: Knee wedge
Intended purpose
A component of the MUTARS system intended to be used for bridging bone defects on the distal medial and lateral aspects of the 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 TiAl6V4 with silver coating on outer contour. Connected to the distal part of the condyles of the MUTARS GenuX femur cemented using femoral spacer screws. Spacers are available for left lateral/right medial & right lateral/left medial applications. Can only be used with a cemented femoral component of the same size. Surfaces of spacers are sandblasted & 0.7 mm deep cement pockets provided to augment cement fixation. Bore holes are provided for the 6.5 mm spacer attachment screws.