FDA.reportPublic FDA data

Duracon

Primary DI
04546540318534
Brand
Duracon
Company
Howmedica Osteonics Corp.
Model
6642-2-645
Catalog number
6642-2-645
Device description
Symmetric 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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052917000
K961483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052917000STRYKER COMPARTMENTAL KNEE SYSTEMHowmedica Osteonics Corp.2005-12-27NPJ
K961483000DURACON ALL POLYETHYLENE PATELLA IIHowmedica Corp.1996-07-09JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540318534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540318534045465403185344546540318534

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
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
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.HRY2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015508TriathlonHowmedica Osteonics Corp.HRY2015-09-24