FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867106987
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-513-1050
Catalog number
AR-513-1050
Device description
IBAL TKA TIB STEM,CM,10MM DX 50MM L
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
00888867106987PrimaryGS10
M150AR51310501SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867106987008888671069878888671069870888867106987

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
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
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161088World Knee CR TiN Cementless Femur - Size 2 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161095World Knee CR TiN Cementless Femur - Size 3 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161101World Knee CR TiN Cementless Femur - Size 4 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161118World Knee CR TiN Cementless Femur - Size 5 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161125World Knee CR TiN Cementless Femur - Size 6 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161132World Knee CR TiN Cementless Femur - Size 7 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161149World Knee CR TiN Cementless Femur - Size 8 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161156World Knee CR TiN Cementless Femur - Size 9 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161163World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161170World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161187World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161194World Knee Cementless Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161200World Knee Cementless Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161217World Knee Cementless Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161224World Knee Cementless Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161231World Knee Cementless Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161248World Knee Cementless Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161255World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161262World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161279World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26