Device Dossier
MK femoral spacer distal silver - Knee wedge
Device Dossier for MK femoral spacer distal 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 used for bridging bone defects on the 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. Connect to the distal part of the condyles of the MUTARS GenuX MK femur cemented with MK spacer screws. Can only be used with a GenuX MK femur cemented of the corresponding size. The surfaces of the spacers are sandblasted & 0.7 mm deep cement pockets are provided to augment bone cement fixation. Bore holes (6.5 mm diameter) are provided for the 6.5 mm MK spacer attachment screws used to secure the spacers to the femoral component.