Device Dossier

UNI SCORE Tibial Fixed Bearing Insert - Unicondylar knee insert

Device Dossier for UNI SCORE Tibial Fixed Bearing Insert - Unicondylar knee insert (Unicondylar knee insert, Class III, sponsor Amplitude). ARTG record,…

Intended purpose

The Uni Score fixed tibial insert forms part of the Uni Score Knee System that is intended for use in any disease to the internal or external femoro-tibial joint of the knee caused by degenerative or congenital disorders, inflammatory, or post-traumatic affection.

Functional description

The Tibial Fixed Bearing Insert is manufactured from UHMWPE. It is a flat insert with a symmetrical profile and has a secure tibial insert locking mechanism that helps minimize micromotion.

TGA Public Summary