Device Dossier
MUTARS L-femoral spacer silver - Knee wedge
Device Dossier for MUTARS L-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 for bridging bone defects on the posterior and 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. The spacers can only be used with a cemented MUTARS GenuX femoral component of the corresponding size. Intended to be used with bone cement and therefore the surfaces of the spacers are sandblasted and 0.7 mm deep cement pockets are provided to augment cement fixation. Bore holes (6.5 mm diameter) are provided for the 6.5 mm spacer attachment screws used to secure the spacers to the femoral component.