Device Dossier

balanSys UNI fixed PE inlay - Unicondylar knee prosthesis

Device Dossier for balanSys UNI fixed PE inlay - Unicondylar knee prosthesis (Unicondylar knee prosthesis, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

ThebalanSys UNI fixed PE inlay forms part of the balanSys UNI knee system that enables anatomical knee replacement and the treatment of uni-compartmental, post-traumatic arthrosis.

Functional description

The balanSys UNI fixed PE is designed for less micro movements and better stress protection. The inlay forms part of the balanSys UNI system which is designed for unicompartmental knee replacement for patients with unicompartmental, post-traumatic arthrosis.

TGA Public Summary