FDA.reportPublic FDA data

Opulent TiNbN Coated Knee

Primary DI
08906067247421
Brand
Opulent TiNbN Coated Knee
Company
MERIL HEALTHCARE PRIVATE LIMITED
Model
MGK-UFCRLD00
Catalog number
MH/BRC/KS/004
Device description
TiNbN Coated Cemented Femoral CR L Size D – A/P 60 mm, M/L 65 mm The Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (Co-CrMo), coated with Titanium Niobium Nitride (TiNbN). The Femoral Component is available in two designs: Cruciate Retaining (CR) and Posterior Stabilized (PS). Each of these designs is further classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus, a total of thirty two (32) models are available for the Femoral Component
Published
2026-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212839000Opulent TiNbN Coated KneeMeril Healthcare Pvt. , Ltd.2021-11-16JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906067247421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906067247421089060672474218906067247421

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-stabilized total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative joint [total knee arthroplasty (TKA)] or for prosthesis revision; it is implanted when the posterior cruciate ligament is sacrificed and uses a “cam and post†mechanism to replace the stabilizing function of the ligament. It includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used in cases where bone stock and mediolateral stability are good in the face of severe deformities or ligament degeneration.

Regulatory Flags#

DUNS number
872346811
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906067247247Opulent TiNbN Coated KneeMGK-UFPSLB00MH/BRC/KS/0042026-10-05
08906067247254Opulent TiNbN Coated KneeMGK-UFPSLC00MH/BRC/KS/0042026-10-05
08906067247261Opulent TiNbN Coated KneeMGK-UFPSLD00MH/BRC/KS/0042026-10-05
08906067247278Opulent TiNbN Coated KneeMGK-UFPSLE00MH/BRC/KS/0042026-10-05
08906067247285Opulent TiNbN Coated KneeMGK-UFPSLF00MH/BRC/KS/0042026-10-05
08906067247292Opulent TiNbN Coated KneeMGK-UFPSLG00MH/BRC/KS/0042026-10-05
08906067247308Opulent TiNbN Coated KneeMGK-UFPSLH00MH/BRC/KS/0042026-10-05
08906067247315Opulent TiNbN Coated KneeMGK-UFPSRA00MH/BRC/KS/0042026-10-05
08906067247322Opulent TiNbN Coated KneeMGK-UFPSRB00MH/BRC/KS/0042026-10-05
08906067247339Opulent TiNbN Coated KneeMGK-UFPSRC00MH/BRC/KS/0042026-10-05
08906067247346Opulent TiNbN Coated KneeMGK-UFPSRD00MH/BRC/KS/0042026-10-05
08906067247353Opulent TiNbN Coated KneeMGK-UFPSRE00MH/BRC/KS/0042026-10-05
08906067247360Opulent TiNbN Coated KneeMGK-UFPSRF00MH/BRC/KS/0042026-10-05
08906067247377Opulent TiNbN Coated KneeMGK-UFPSRG00MH/BRC/KS/0042026-10-05
08906067247384Opulent TiNbN Coated KneeMGK-UFPSRH00MH/BRC/KS/0042026-10-05
08906067247391Opulent TiNbN Coated KneeMGK-UFCRLA00MH/BRC/KS/0042026-10-05
08906067247407Opulent TiNbN Coated KneeMGK-UFCRLB00MH/BRC/KS/0042026-10-05
08906067247414Opulent TiNbN Coated KneeMGK-UFCRLC00MH/BRC/KS/0042026-10-05
08906067247438Opulent TiNbN Coated KneeMGK-UFCRLE00MH/BRC/KS/0042026-10-05
08906067247445Opulent TiNbN Coated KneeMGK-UFCRLF00MH/BRC/KS/0042026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906067247247Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247254Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247261Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247278Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247285Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247292Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247308Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247315Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247322Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247339Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247346Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247353Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247360Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247377Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247384Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247391Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247407Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247414Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247438Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247445Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247452Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247469Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247476Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247483Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247490Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247506Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247513Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247520Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247537Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247544Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05