Device Dossier
MUTARS GenuX Mk FB PE Insert - Prosthesis, knee, internal, insert component
Device Dossier for MUTARS GenuX Mk FB PE Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
A PE insert component of the MUTARS system used as part of a knee replacement.Primary indication for the use of the MUTARS system is after bone resection because of tumour. Further indications for the use of the MUTARS system are massive bone loss,such as Morbus Gorham or for revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis.
Functional description
Made of UHMW-PE. Inlay for the MUTARS GenuX MK Tibia that doesn’t allow for rotation in the MUTARS rotating hinge knee system. The inlay has elongated feet that snap into the tibial tray. Includes x-ray wire for visibility made of TiAl6V4. It has a symmetric flat-on-flat design and a minimum thickness of 5 mm. A ventral deepening reduces soft tissue irritation and a circular bevelling avoids overhang at rotation. More flexion is guaranteed by the dorsal flattening and chamfer for more flexion.