Device Dossier

GENUS FIXED Cemented Ti6Al4V tibial tray - Uncoated knee tibia prosthesis, metallic

Device Dossier for GENUS FIXED Cemented Ti6Al4V tibial tray - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class…

Intended purpose

A tibial component of a tricompartmental fixed-bearing 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

Composed of Ti6Al4V. A fixed-bearing tibial component showing a non-anatomical shape and a keel to be anchored to the bone with bone cement. Keel features two delta-shaped wings. Central part is truncated cone-shaped, to anchor tibial stems. Locking system for tibial insert - a step to be coupled to flexible clips located in the anterior part of the tibial insert; posterior part, a stair to be coupled with a groove located at the base of the tibial insert avoids detachment of the components.

TGA Public Summary