FDA.reportPublic FDA data

Unix

Primary DI
07613327101416
Brand
Unix
Company
Howmedica Osteonics Corp.
Model
4540-0210
Catalog number
4540-0210
Device description
Tibial Bearing Insert
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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923011000OSTEONICS UNIX UNICOMPARTMENTALOsteonics Corp.1993-11-30HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327101416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327101416076133271014167613327101416

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated unicondylar knee tibia prosthesis, polyethyleneA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, and its implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
07613327127447INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127577INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127584INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24