Device Dossier
GENUS FIXED cementless tibial tray Ti-Por+HA - Coated knee tibia prosthesis
Device Dossier for GENUS FIXED cementless tibial tray Ti-Por+HA - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Adler…
- GMDN category: Coated knee tibia prosthesis
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
Ti6Al4V with porous titanium & HA coating. A fixed-bearing tibial component showing a non-anatomical shape and a keel to be anchored to the bone. Keel features 2 delta-shaped wings. Central part is truncated cone-shaped to anchor tibial stems. Locking system for tibial insert - step to be coupled to flexible clips located in the anterior part of tibial insert; posterior part, stair to be coupled with a groove located at the base of tibial insert avoids detachment of components.