Device Dossier

MUTARS Proximal Femur TiAl6V4 - Uncoated hip femur prosthesis, modular

Device Dossier for MUTARS Proximal Femur TiAl6V4 - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor…

Intended purpose

Proximal femoral replacement component indicated for tumours in the area of the proximal femur or other major bone defects including hip joint arthroplasty as hemi prosthesis or total hip replacement. 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

Composed of titanium alloy TiAl6V4. Proximal Femur component of the MUTARS (Modular Universal Tumor and Revision System) system in two different lengths of 50 mm and 70 mm with taper (12/14), with retention rings for fixation of the attachment tube and various stems. The treatment can be adjusted with the use of the extension pieces of 20 mm increments. The Proximal Femur allows the adjustment of the antetorsion angles in 5 degree increments.

TGA Public Summary