FDA.reportPublic FDA data

Nuffield Total Knee

Primary DI
05055196910010
Brand
Nuffield Total Knee
Company
CORIN LTD
Model
117.305
Catalog number
117.305
Device description
NTK PATELLA
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K931960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931960000NUFFIELD TOTAL KNEETurnkey Intergration USA, Inc.1994-10-07JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055196910010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055196910010050551969100105055196910010

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene patella prosthesisAn artificial kneecap (patellar component) made of polyethylene (PE) and implanted during primary or revision bicondylar knee joint replacement. It is a sterile device designed to articulate with a prosthetic distal femoral component and is implanted on the back of the natural patella with bone cement.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441285659866lucinda.gerber@coringroup.com
+441285659866rachel.king@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139247750Unity Total Knee System112690911269092026-10-23
05056139247804Unity Total Knee System112710911271092026-10-23
05056139247811Unity Total Knee System112720911272092026-10-23
05056139247828Unity Total Knee System112730911273092026-10-23
05056139247835Unity Total Knee System112740911274092026-10-23
05056139247941Unity Total Knee System112721011272102026-10-23
05056139247958Unity Total Knee System112721111272112026-10-23
05056139247965Unity Total Knee System112721211272122026-10-23
05056139247972Unity Total Knee System112721411272142026-10-23
05056139247989Unity Total Knee System112721611272162026-10-23
05056139248047Unity Total Knee System112731011273102026-10-23
05056139248054Unity Total Knee System112731111273112026-10-23
05056139248061Unity Total Knee System112731211273122026-10-23
05056139248078Unity Total Knee System112731411273142026-10-23
05056139248085Unity Total Knee System112731611273162026-10-23
05056139248146Unity Total Knee System112741011274102026-10-23
05056139248153Unity Total Knee System112741111274112026-10-23
05056139248160Unity Total Knee System112741211274122026-10-23
05056139248177Unity Total Knee System112741411274142026-10-23
05056139248184Unity Total Knee System112741611274162026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247750Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248153Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248160Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139248597Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249334Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139249341Unity Total Knee SystemCORIN LTDJWH2026-10-23