FDA.reportPublic FDA data

Kinemax

Primary DI
07613327046717
Brand
Kinemax
Company
Howmedica Osteonics Corp.
Model
6476-5-400
Catalog number
6476-5-400
Device description
Primary Knee Tibial Baseplate
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
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
K910500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910500000HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEMHowmedica Corp.1991-05-06JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327046717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327046717076133270467177613327046717

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, metallicAn implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed 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
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07613327012866V40 Head6260-5-1286260-5-1282015-09-24
07613327012873V40 Head6260-5-1326260-5-1322015-09-24
07613327012880V40 Head6260-5-2266260-5-2262015-09-24
07613327012897V40 Head6260-5-2286260-5-2282015-09-24
07613327012903V40 Head6260-5-2326260-5-2322015-09-24
07613327012941V40 Head6260-5-4266260-5-4262015-09-24
07613327012958V40 Head6260-5-4286260-5-4282015-09-24
07613327012965V40 Head6260-5-4326260-5-4322015-09-24
07613327012972V40 Head6260-5-6286260-5-6282015-09-24
07613327019704Restoration5096-46255096-46252015-09-24
07613327019711Restoration5096-46155096-46152015-09-24
07613327019728Restoration5096-46205096-46202015-09-24
07613327019735Restoration5096-50155096-50152015-09-24
07613327019742Restoration5096-50205096-50202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24