Device Dossier
Mobile-bearing total knee prosthesis
Device Dossier for Mobile-bearing total knee prosthesis (Mobile-bearing total knee prosthesis, Class IIb, sponsor B Braun). ARTG record, intended…
- GMDN category: Mobile-bearing total knee prosthesis
- Sponsor: B Braun
Intended purpose
This device is used as a component part of a human knee endoprosthesis in combination with Aesculap knee endoprosthetic components. A sterile implantable artificial substitute component for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee replacement (TKR)] or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for rotation to minimise wear/loosening problems and to allow greater range of motion for the joint.