Device Dossier

MK tibial spacer silver - Knee wedge

Device Dossier for MK tibial spacer silver - Knee wedge (Knee wedge, Class III, sponsor Life Healthcare). ARTG record, intended purpose, GMDN category —…

Intended purpose

A component of the MUTARS system intended for bridging bone defects in 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. Bilateral configuration & connected below a MUTARS GenuX MK tibia cemented component by screws. Can only be combined with a tibial component of the corresponding size. Symmetrical & have slots for the fins of the tibial component. A flattening at the front of the spacer is provided for preserving the tibial tuberosity & holes for the fixation of the soft tissue. To be used with bone cement, the surfaces have a sandblasted finish.

TGA Public Summary