Opulent Knee System
· Knee Implants
Opulent Knee System
| Technical Blueprint Specification | Clinical Value |
|---|---|
Coating Thickness | 3-6 μm |
Roughness | ≤ 0.05 μm |
Adhesive strength (according to Rockwell indentation test) | HF 1-2 |
Coating hardness | ca. 2,400 HV (0.1 N) |
Friction against UHMWPE | 0.04-0.07 |
Liquid contact angle | Reduction of the liquid contact angle by 20%, result: improved wettability of the surface compared to uncoated CoCrMo surfaces |
Coating
TiNbN (Titanium Niobium Nitride) ceramic surface coating
Wear resistance
Very high wear resistance towards bone cement
Wear
Reduction of UHMWPE wear
Sensitization test according to 10993-1
No sensitization from TiNbN
Irritation test according to ISO 10993-1
No irritant reactions from TiNbN coating
Implantation according to DIN EN ISO 10993-6
No product-related tissue reactions
Allergy potential
Release of ions was reduced to the detection limit
Cytotoxicity
Not cytotoxic
Genotoxicity
Not genotoxic
Primary Material
Cobalt-Chromium Alloy
Anatomical Wizard
Clinical Sizing Precision
Total Knee Replacement System with TiNbN Coating
The Opulent Knee System features a TiNbN ceramic coating with a roughness of ≤ 0.05 μm and a friction coefficient of 0.04-0.07 against UHMWPE, which contributes to very high wear resistance. This reduces UHMWPE wear and improves the articulation precision of the implant, leading to optimized kinematic function and potentially longer implant lifespan.
The TiNbN coating demonstrates excellent biocompatibility, evidenced by sensitization and irritation tests according to ISO 10993-1 standards, which show no sensitization or irritant reactions. Furthermore, implantation tests per DIN EN ISO 10993-6 indicate no product-related tissue reactions, with ion release reduced to the detection limit, confirming its biocompatible nature.
The TiNbN coating reduces the liquid contact angle by 20%, leading to improved wettability of the surface, this results in better bone cement adhesion. Furthermore, the coating's adhesive strength (HF 1-2 per Rockwell indentation test) and high wear resistance ensures stability during and after implantation procedures.
This product is manufactured by Meril Life Sciences and is distributed by Agile Healthcare across all districts of Telangana.
Yes, all Meril Life Sciences products distributed by Agile Healthcare, including the Opulent Knee System, strictly adhere to CDSCO guidelines and ISO 13485:2016 quality standards.
The Opulent Knee System is constructed using Cobalt-Chromium Alloy, ensuring high biocompatibility and durability.