Device Dossier

GENUS CR MOBILE Tibial insert - Prosthesis, knee, internal, insert component

Device Dossier for GENUS CR MOBILE Tibial insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

Intended purpose

A tibial insert component of a tricompartmental rotating platform prosthesis to be used in PCL (posterior cruciate ligament) retaining/sacrificing 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

Constructed from UHMWPE. The Genus tibial insert has; an anterior chamfer to avoid risk of patellar conflict particularly with low patellas and a posterior chamfer to avoid impingements with the PCL. The articular surface posterior lip has been elevated 2.9mm in order to avoid conflicts with the femoral posterior cortex and allow a further flexion increase.

TGA Public Summary