FDA.reportPublic FDA data

Avon

Primary DI
07613327049312
Brand
Avon
Company
Howmedica Osteonics Corp.
Model
6430-0-030
Catalog number
6430-0-030
Device description
Femoral Joint Patella Component
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K020841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020841000AVON PATELLAR COMPONENTHowmedica Osteonics Corp.2002-04-11KRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327049312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327049312076133270493127613327049312

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
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
E31442411410SignatureMaterialise NVHRY2026-09-24
E31442422650SignatureMaterialise NVHRY2026-09-24
E31442422651SignatureMaterialise NVHRY2026-09-24
E31442422652SignatureMaterialise NVHRY2026-09-24
E31442422653SignatureMaterialise NVHRY2026-09-24
E31442422660SignatureMaterialise NVHRY2026-09-24
E31442422661SignatureMaterialise NVHRY2026-09-24
E31442422662SignatureMaterialise NVHRY2026-09-24
E31442422663SignatureMaterialise NVHRY2026-09-24
E31442422670SignatureMaterialise NVHRY2026-09-24
E31442422671SignatureMaterialise NVHRY2026-09-24
E31442422672SignatureMaterialise NVHRY2026-09-24
E31442422673SignatureMaterialise NVHRY2026-09-24
00192629082854EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082953EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082960EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082977EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082984EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629082991EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083004EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18
00192629083011EVOLUTIONMicroport Orthopedics Inc.HRY2026-09-18