Device Dossier

balanSys UNI fixed tibial plateau cemented - Unicondylar knee prosthesis

Device Dossier for balanSys UNI fixed tibial plateau cemented - Unicondylar knee prosthesis (Unicondylar knee prosthesis, Class III, sponsor Enovis…

Intended purpose

The balanSys UNI fixed tibial plateau cemented 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 cemented fixed tibial plateau is an asymmetric anatomic design, that forms part of the balanSys UNI system which is designed for unicompartmental knee replacement for patients with unicompartmental, post-traumatic arthrosis.

TGA Public Summary