FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867033993
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-501-TBD9
Catalog number
AR-501-TBD9
Device description
IBALANCE UKA TIBIAL BEARING, SIZE 4, 9MM
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867033993PrimaryGS10
M150AR501TBD92SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867033993008888670339938888670339930888867033993

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345711014MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711021MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711038MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711229MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711236MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711243MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711434MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711441MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711458MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711649MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711656MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711663MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711854MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711861MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345711878MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712066MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712073MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712080MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712271MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712288MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712295MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712486MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712493MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630345712509MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752568MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752575MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752582MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752599MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752605MOTO Partial Knee SystemMedacta International SAHSX2025-08-05
07630542752667MOTO Partial Knee SystemMedacta International SAHSX2025-08-05