FDA.reportPublic FDA data

Kinemax

Primary DI
07613327046748
Brand
Kinemax
Company
Howmedica Osteonics Corp.
Model
6479-4-911
Catalog number
6479-4-911
Device description
Patella
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051948000AVON PATELLO-FEMORAL JOINT PROSTHESISHowmedica Osteonics Corp.2005-10-21KRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327046748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327046748076133270467487613327046748

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327127423INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327049305AvonHowmedica Osteonics Corp.KRR2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24