Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Polyethylene patella prosthesis FDA UDI
Device Name: PATELLA IMPLANT DOME, 37 X 10MM, VIT-E FDA UDI
Model / Reference: AR-524-PSD0 FDA UDI
Description: PATELLA IMPLANT DOME, 37 X 10MM, VIT-E FDA UDI

Identifiers

Catalog Number: AR-524-PSD0 FDA UDI
Primary DI / UDI-DI: 00888867231405 FDA UDI
FDA Product Code: KRR FDA UDI
GMDN Term: Polyethylene patella prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3540 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: Polyethylene patella prosthesis

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

Similar devices

Also classified as Polyethylene patella prosthesis.

VANGUARD KNEE SYSTEM — Biomet Orthopedics, Inc. · Class II
Duracon — Howmedica Osteonics Corp. · Class II
PERSONA® — Zimmer, Inc. · Class II
S-ROM NOILES — DEPUY (IRELAND) · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
ADVANCE® — MicroPort Orthopedics Inc. · Class II
Unity Total Knee System — CORIN LTD · Class II
Proven Gen-Flex PS Knee System — GLOBUS MEDICAL, INC. · 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 140cc7cf-2c84-4aa4-90f3-5aed59abdc8e 35 fields · synced Jun 8, 2026