Device Dossier
MUTARS Tibial stem cemented - Knee stem
Device Dossier for MUTARS Tibial stem cemented - Knee stem (Knee stem, Class III, sponsor Life Healthcare). ARTG record, intended purpose, GMDN category…
- GMDN category: Knee stem
Intended purpose
A cemented Tibial Stem component of the MUTARS system used as part of a knee or diaphysis replacement prosthesis. 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.
Functional description
Made of CoCrMo casting alloy, length 120 mm. Allows for a diaphyseal anchorage of the knee joint replacement in the tibia. It has a sandblasted surface and is intended to be used with bone cement. Has the MUTARS fit (diam. 16 mm H7g6) and serration (72 teeth) which allows an adjustment of the antetorsion angle in 5 degree steps. The stem is straight with a hexagonal cross section for rotation stability. It also has a collar at the proximal end to prevent subsidence.