Device Dossier

MUTARS Genux MK Coupling TiNbN - Rotating hinged total knee prosthesis

Device Dossier for MUTARS Genux MK Coupling TiNbN - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor Life…

Intended purpose

A locking mechanism for the coupling of knee joint components used in the MUTARS system as part of a total knee 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 CoCrMo with TiNbN coating. The MUTARS GenuX MK Coupling connects the MUTARS femoral components with the MUTARS tibial components and creates therefore a rotating hinge knee system. It restrains the movement in the knee joint and replaces the removed ligament. The coupling consists of three components: the spherical cap, the locking bolt, and the connecting pin. The MUTARS GenuX MK Coupling can only be combined with the MUTARS GenuX MK Tibia.

TGA Public Summary