FDA.reportPublic FDA data

Arthrex®

Primary DI
M150AR521TBD22
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-521-TBD2
Catalog number
AR-521-TBD2
Device description
UKA TIBIAL BEARING, SIZE 4, 12MM, VIT-E
Published
2017-01-30
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867233232PrimaryGS10
M150AR521TBD22SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867233232008888672332328888672332320888867233232

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
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867179493Arthrex®AR-8835L-08SAR-8835L-08S2017-04-07
00888867186293Arthrex®AR-8835-08SAR-8835-08S2017-03-03
00888867202733Arthrex®AR-8948W-2045AR-8948W-20452017-02-25
00888867237612Arthrex®AR-8827L-08SAR-8827L-08S2017-05-11
00888867238602Arthrex®AR-1927PSF-475AR-1927PSF-4752017-05-05
00888867483927Arthrex®AR-4020C-06DAR-4020C-06D2025-11-06
00888867525924Arthrex®AR-7269RAR-7269R2025-10-20
00888867456174Arthrex®AR-3610NDF-1AR-3610NDF-12025-11-14
00888867456181Arthrex®AR-3610NDF-2AR-3610NDF-22025-11-14
00888867456198Arthrex®AR-3610NDF-3AR-3610NDF-32025-11-14
00888867456204Arthrex®AR-3610NDF-4AR-3610NDF-42025-11-14
00888867525931Arthrex®AR-7269R-1AR-7269R-12025-10-20
00888867465220Arthrex®AR-1588SBR-RTAR-1588SBR-RT2025-06-23
00888867465237Arthrex®AR-1588SBR-RT-IBAR-1588SBR-RT-IB2025-06-23
00888867465244Arthrex®AR-1588SBR-RT-IBRAR-1588SBR-RT-IBR2025-06-23
00888867501324Arthrex®AR-1588SBR-RTT-IBAR-1588SBR-RTT-IB2025-06-23
00888867501331Arthrex®AR-1588SBR-RTT-IBRAR-1588SBR-RTT-IBR2025-06-23
00888867458048Arthrex®AR-S1000-C4AR-S1000-C42024-01-23
00888867426023Arthrex®AR-3711AR-37112023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
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07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
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07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
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07613327051148INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
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07613327051179INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
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07613327051216INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
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