Device Dossier
MK tibial spacer silver LL-RM/ RL-LM - Knee wedge
Device Dossier for MK tibial spacer silver LL-RM/ RL-LM - Knee wedge (Knee wedge, Class III, sponsor Life Healthcare). ARTG record, intended purpose,…
- GMDN category: Knee wedge
Intended purpose
A component of the MUTARS system intended for bridging bone defects in the area of the proximal tibia. 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. Can only be used with cemented GenuX MK tibial component of the corresponding size. Slots included for the fins of the tibial component & flattening at the front of the spacer is provided for preserving the tibial tuberosity. Holes are provided for the fixation of soft tissues. The spacers have 6.5 mm diameter bore holes for screw attachment to the distal aspect of the cemented MUTARS GenuX MK tibial component. For use with bone cement.