Device Dossier

GENUS UNI tibial insert - Unicondylar knee insert

Device Dossier for GENUS UNI tibial insert - Unicondylar knee insert (Unicondylar knee insert, Class III, sponsor Adler Ortho). ARTG record, intended…

Intended purpose

A tibial insert component of a Medial unicompartmental knee replacement prosthesis. Indicated when; • Medial compartment osteoarthritis or avascular necrosis with a well-preserved lateral compartment presenting an intact meniscus and full thickness cartilage. • Normally functioning Anterior and Posterior cruciate ligaments. • Varus deformity able to be passively corrected and in any case lower than 15°. • Flexion contracture less than 15°. • Patello-femoral arthritis is not considered a contraindication. • Age, weight and patient activity level are not considered a contraindication for Unicompartmental knee replacement.

Functional description

A tibial insert component of a unicompartmental knee replacement prosthesis composed of UHMW-PE. Anterior chamfer to avoid potential patellar conflicts. Outer edge rounded to cover the Metal Back, to avoid potential conflicts between metal and soft parts. Flat articular surface to facilitate a linear contact with the condyle and better distribute the loading forces.

TGA Public Summary