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Attune 1506-40-002

by Depuy (Ireland)

Ref 1506-40-002Model ATTUNE Knee System Revision FB Tibial Base

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

CE MDR 510(k)

Valid until

25 Aug 2027

CE MDR certificate

FDA recalls

None ongoing

5 closed

Documents

2 certificates

Certifier BSI Group The Netherlands B.V.

510(k) K241000

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a0011282 Basic UDI-DI 10603295042761UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK241000 Date11 Jul 2024IssuedStatusActive
United StatesGUDID listing GUDID Number10603295042761 UDI-DI Date5 Dec 2016ListedStatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 755211 Active Reissued Removed from EUDAMED

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    28 Sep 2026
    Expires
    27 Sep 2031
  • MDR 755211 Expiring Supplemented Expires in 287 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    31 Aug 2026
    Expires
    25 Aug 2027
    Reason
    Change approved

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  • Withdrawn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
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Attune
Generic name
Uncoated knee tibia prosthesis, metallic
Device name
Revision FB Tibial Base
Model / Ref / Catalog
1506-40-002, ATTUNE Knee System Revision FB Tibial Base, 150640002
Primary DI / UDI-DI
10603295042761
Basic UDI-DI
0603295a0011282
510(k) Number
FDA product code
MBH, JWH
EMDN code
P090905020102 Revision knee prostheses fixed bearing tibial plates
GMDN term
Uncoated knee tibia prosthesis, metallic
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3565, 888.3560
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

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Category: Uncoated knee tibia prosthesis, metallic

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Cleared under the same submission (K241000)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (18)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No