Device Dossier

GENUS CR Fixed-Bearing tibial insert - Prosthesis, knee, internal, insert component

Device Dossier for GENUS CR Fixed-Bearing tibial insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

Intended purpose

A tibial insert component of a tricompartmental fixed-bearing prosthesis to be used in PCL (Posterior Cruciate Ligament)retaining TKR (Total Knee Replacement) for primary and revision surgery. Main indications: - Primary and secondary arthrosis - Rheumatoid arthritis - Bone necrosis - Revisions, where other devices or treatments have failed

Functional description

Composed of UHMW-PE. A tibial insert component of a fixed bearing total knee replacement prosthesis which allows the cruciate ligament to be retained. It features a non-anatomical shape and a symmetric design and a non-congruent tibio-femoral articular surface. A locking system and two flexible clips allows the insert to be fixed to the GENUS TIBIAL TRAY FB. In the posterior part, a groove located on the tibial tray avoids the detachment of the components.

TGA Public Summary