Skip to content

Attune Knee System

by DePuy Ireland UC 157 variants

Ref 2511-11-304510(k) K241000

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241000↗

+1 more

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a004528V Basic UDI-DI 10603295450634UDI-DIDate4 Nov 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK241000 Date11 Jul 2024IssuedStatusActive
United StatesGUDID listing GUDID Number10603295450634 UDI-DI Date10 Dec 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0632-2022 FDA Class II initiated 5 Jan 2022
    • Terminated Z-0631-2022 FDA Class II initiated 5 Jan 2022

    May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

    • Terminated Z-2348-2021 FDA Class II initiated 1 Jul 2021

    Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

  • 2 recalls, same reason

    • Terminated Z-1703-2018 FDA Class II initiated 16 Apr 2018
    • Terminated Z-1704-2018 FDA Class II initiated 16 Apr 2018

    There may be burrs on the extraction hole threads.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Attune Knee System EUDAMED
Attune GUDID
Generic Name
Knee tibia prosthesis trial, reusable
Device Name
Ancillary Knee Trial Prosthesis
Model / Ref / Catalog
2511-11-304, 251111304
Primary DI / UDI-DI
10603295450634
Basic UDI-DI
0603295a004528V
Direct Marketing DI
10603295450634
FDA Product Code
HWT
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Knee tibia prosthesis trial, reusable
Device Class
Class I
Regulation Number
888.4800
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
IE-MF-000007377
FDA applicant
Depuy(Ireland)

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Reusable
  • CMR Substance
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No