FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867187900
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-513-T7
Catalog number
AR-513-T7
Device description
iBalance TKA, Modular Tibial Tray, Sz 7
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867187900PrimaryGS10
M150AR513T71SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867187900008888671879008888671879000888867187900

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
00888867340183Arthrex®AR-D8400EXAR-D8400EX2019-10-06
00888867504288Arthrex®AR-9953AR-05AR-9953AR-052026-05-21
00888867504295Arthrex®AR-9953AR-03AR-9953AR-032026-05-21
00888867504318Arthrex®AR-9953AR-07AR-9953AR-072026-05-21
00888867504356Arthrex®AR-9953AR-09AR-9953AR-092026-05-21
00888867504363Arthrex®AR-9953AR-11AR-9953AR-112026-05-21
00888867504387Arthrex®AR-9953AR-13AR-9953AR-132026-05-21
00888867504394Arthrex®AR-9953AL-13AR-9953AL-132026-05-21
00888867504400Arthrex®AR-9953AR-15AR-9953AR-152026-05-21
00888867504417Arthrex®AR-9953AL-15AR-9953AL-152026-05-21
00888867504424Arthrex®AR-9953AR-03SAR-9953AR-03S2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327014846TriathlonHowmedica Osteonics Corp.MBH2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327000023INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000030INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000047INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000054INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000061INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000078INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000085INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000092INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000108INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000115INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000122INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000139INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000146INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000153INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000160INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000177INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000184INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000191INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000207INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000214INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000221INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000238INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000245INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000252INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000269INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000276INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24