Device Dossier
Opulent™ Total Knee System - TiNbN Coated Tibial Base Plate - Coated knee tibia prosthesis
Device Dossier for Opulent™ Total Knee System - TiNbN Coated Tibial Base Plate - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III,…
- GMDN category: Coated knee tibia prosthesis
Intended purpose
Opulent™ Total Knee System is indicated to be used for knee arthroplasty in patients with degenerative joint diseases including osteoarthritis and rheumatoid arthritis.
Functional description
The device is TiNbN Coated tibial base plate is offered in 8 different sizes (A/P and M/L). The tibial base plate is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy and is coated with TiNbN (Titanium Niobium Nitride) Coating. It is intended for cemented use with a tibial articular surface, it replaces the proximal tibial articulating surface in a measured resection technique.