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Attune 1516-40-705

by Depuy (Ireland)

Ref 1516-40-705Model ATTUNE Knee System Cemented FB Tibial Insert

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

9 Jul 2029

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 755208 Date29 Jun 2026IssuedStatusActive expires 9 Jul 2029
United StatesGUDID listing GUDID Number10603295050209 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 755208 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    29 Jun 2026
    Expires
    9 Jul 2029
    Reason
    Change approved

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1267-2023 FDA Class II initiated 15 Feb 2023

    The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Attune
Generic Name
Tibial insert
Device Name
Cemented FB Tibial Insert
Model / Ref / Catalog
1516-40-705, ATTUNE Knee System Cemented FB Tibial Insert, 151640705
Primary DI / UDI-DI
10603295050209
Basic UDI-DI
0603295a002548P
510(k) Number
FDA Product Code
OIY, JWH
EMDN Code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN Term
Tibial insert
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560
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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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No