Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Cruciate-retaining total knee prosthesis FDA UDI
Device Name: IBAL TKA TIB BEA-RING CR + SZ 5,11MM FDA UDI
Model / Reference: AR-503-A511 FDA UDI
Description: IBAL TKA TIB BEA-RING CR + SZ 5,11MM FDA UDI

Identifiers

Catalog Number: AR-503-A511 FDA UDI
Primary DI / UDI-DI: 00888867103825 FDA UDI
FDA Product Code: HSX FDA UDI
KRR FDA UDI
MBH FDA UDI
GMDN Term: Cruciate-retaining total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 FDA UDI
888.3540 FDA UDI
888.3565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cruciate-retaining total knee prosthesis

Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cruciate-retaining total knee prosthesis.

Columbus® UC — AESCULAP, INC. · Class II
Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC · Class II
UKNEE Tibial insert, plained — UNITED ORTHOPEDIC CORP. · Class II
B-P TOTAL KNEE SYSTEM — ENDOTEC, INC. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Arthrex, Inc.

Sources (1)

FDA UDI 48f8ec62-c5ad-4ddb-b7a1-5b752e47ba25 35 fields · synced May 30, 2026