Device Dossier

BalanSys UNI vitamys Inlay Fix - Unicondylar knee prosthesis

Device Dossier for BalanSys UNI vitamys Inlay Fix - Unicondylar knee prosthesis (Unicondylar knee prosthesis, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

The balanSys UNI fixed vitamys inlay forms part of the balanSys UNI knee system that is intended for treating unicompartmental degenerative joint diseases in the medial or lateral femorotibial compartment in skeletally mature patients. Indications for use include painful and / or disabling unicompartmental joint disease in the femorotibial compartment resulting from osteoarthritis, avascular necrosis, or post-traumatic arthritis.

Functional description

The balanSys UNI fixed vitamys inlay is designed for less micro movements and better stress protection. The inlay has a posterior locking mechanism for secure fixation. vitamys is a vitamin E-enhanced, highly cross-linked polyethylene that is designed to deliver superior resilience and a long service life.

TGA Public Summary