Skip to content

ARTICUL/EZE Ceramic Heads

by DePuy Ireland UC

510(k) K222296

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222296↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222296 Date6 Jan 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ARTICUL/EZE Ceramic Heads are a class of hip joint components designed for metal-ceramic articulation, combining a ceramic femoral head with a metallic femoral stem or neck. These components are intended for use in total hip arthroplasty, providing a durable and low-friction bearing surface to improve joint function and longevity. The ceramic heads are engineered to reduce wear and potential metal ion release compared to traditional metal-on-metal or metal-on-polyethylene bearings.

These heads are supplied in a range of sizes, including diameters of 22.225 mm and 40 mm, with neck lengths varying from -2 mm to +12 mm, offering surgeons flexibility in biomechanical reconstruction. The device is manufactured by DePuy Ireland UC and is classified under product code LZO, regulated under 21 CFR 888.3353 for hip joint metal/ceramic/polymer components. It is cleared for single-use applications in orthopedic surgery and has received FDA 510(k) clearance (K222296) and MDR authorization.

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are the ARTICUL/EZE Ceramic Heads designed for reuse in multiple surgeries, or are they intended for single-use only?

    The ARTICUL/EZE Ceramic Heads are explicitly cleared for single-use applications in orthopedic surgery. This designation aligns with their classification as a sterile, implantable device intended to minimize infection risks and ensure consistent performance during a single procedure.

  • What sizes and configurations are available for the ARTICUL/EZE Ceramic Heads, and how do they accommodate different patient anatomies?

    The device is available in two primary diameters (22.225 mm and 40 mm) and offers adjustable neck lengths ranging from -2 mm to +12 mm, allowing surgeons to tailor the implant to the patient’s specific biomechanics during total hip arthroplasty. This flexibility helps optimize joint alignment and stability.

  • How does the ceramic material in these heads compare to traditional metal-on-metal or metal-on-polyethylene bearings in terms of wear and durability?

    The ARTICUL/EZE Ceramic Heads are engineered to provide a low-friction bearing surface that reduces wear and minimizes potential metal ion release—a known concern with metal-on-metal implants. This design aims to improve joint longevity and reduce complications associated with particulate debris or corrosion.

  • What regulatory pathways have been followed for the ARTICUL/EZE Ceramic Heads, and how does this affect their availability?

    The device has undergone FDA 510(k) clearance (K222296) under the traditional review process, with a decision classified as *Substantially Equivalent* (SESE) by the Orthopedic (OR) Advisory Committee. Additionally, it holds MDR authorization, ensuring compliance with both U.S. and EU regulatory standards for hip joint metal/ceramic/polymer components.