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
07613327027730Triathlon5610-F-1015610-F-1012015-09-24
07613327027747Triathlon5610-F-2015610-F-2012015-09-24
07613327027754Triathlon5610-F-1025610-F-1022015-09-24
07613327027761Triathlon5610-F-2025610-F-2022015-09-24
07613327027778Triathlon5610-F-3015610-F-3012015-09-24
07613327027785Triathlon5610-F-3025610-F-3022015-09-24
07613327027792Triathlon5610-F-4015610-F-4012015-09-24
07613327027808Triathlon5610-F-4025610-F-4022015-09-24
07613327027815Triathlon5610-F-5025610-F-5022015-09-24
07613327027822Triathlon5610-F-6015610-F-6012015-09-24
07613327027839Triathlon5610-F-6025610-F-6022015-09-24
07613327027846Triathlon5610-F-5015610-F-5012015-09-24
07613327207163INSTRUMENT5510-T-1015510-T-1012016-09-24
07613327208832INSTRUMENT1100-12251100-12252016-09-24
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24

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
00888867106697Arthrex®ARTHREX, INC.KRR2017-02-15
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