FDA.reportPublic FDA data

NovoKnee Total Knee System

Primary DI
00811382037641
Brand
NovoKnee Total Knee System
Company
Novosource, LLC
Model
3120-5074
Catalog number
3120-5074
Device description
Universal Handle Metal
Published
2020-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K123339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123339000TK1 TOTAL KNEE SYSTEMNovosource, Inc.2013-04-11JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811382037641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811382037641008113820376418113820376410811382037641

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3045542167xx@xx.xx

Regulatory Flags#

DUNS number
081034828
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811382037658NovoHip Total Hip System1500-10161500-10162020-05-26
00811382037672NovoKnee Total Knee System3220-50243220-50242020-05-26
00811382037689NovoHip Total Hip System1345-36011345-36012020-11-03
00811382037696NovoHip Total Hip System1345-36021345-36022020-11-03
00811382037702NovoHip Total Hip System1345-36031345-36032020-11-03
00811382037719NovoHip Total Hip System1345-36041345-36042020-11-03
00811382037795NovoHip Total Hip System1345-28011345-28012021-04-20
00811382037801NovoHip Total Hip System1345-28021345-28022021-04-20
00811382037818NovoHip Total Hip System1345-28031345-28032021-04-20
00811382037825NovoHip Total Hip System1345-32011345-32012021-04-20
00811382037832NovoHip Total Hip System1345-32021345-32022021-04-20
00811382037849NovoHip Total Hip System1345-32031345-32032021-04-20
00811382037856NovoHip Total Hip System1345-32041345-32042021-04-20
00811382037726NovoKnee Total Knee System3120-51003120-51002024-07-19
00811382039287NovoHip Total Hip System1445-28051445-28052024-04-09
00811382039294NovoHip Total Hip System1445-32051445-32052024-04-09
00811382039300NovoHip Total Hip System1445-36051445-36052024-04-09
00811382039089NovoKnee Total Knee System3115-11013115-11012023-08-18
00811382039096NovoKnee Total Knee System3115-12013115-12012023-08-18
00811382039102NovoKnee Total Knee System3115-11023115-11022023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809945895311EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
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08809945895335EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895342EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895359EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895366EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895373EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895380EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895397EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895403EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
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08906067247339Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247346Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
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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
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08906067247407Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247414Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247421Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247438Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05