Device Dossier
MK femoral spacer posterior silver - Knee wedge
Device Dossier for MK femoral spacer posterior 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 in the posterior area 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 in the posterior part of the condyles of the MUTARS GenuX MK femur cemented by the means of screws (MK screw for spacer). Can only be used with a GenuX MK femur cemented of the corresponding size. Upper and bottom surfaces are sandblasted and 0.7 mm deep cement pockets are provided to augment bone cement fixation. For the connection to the femoral component by screws, diameter 6.5 mm bore holes are provided.