Device Dossier

Opulent™ Total Knee System - TiNbN Coated Femoral Component – Posterior Stabilized (PS) - Coated knee femur prosthesis

Device Dossier for Opulent™ Total Knee System - TiNbN Coated Femoral Component – Posterior Stabilized (PS) - Coated knee femur prosthesis (Coated knee…

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 a TiNbN Coated Posterior Stabilized (PS) femoral component of a total knee replacement system offered in left/right configurations in 8 Sizes (A/P, M/L) to accommodate varying anatomy. The femoral component is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy and is coated with TiNbN (Titanium Niobium Nitride) Coating. It is intended for cemented use to replace distal femur surfaces in a measured resection technique.

TGA Public Summary