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Attune 1516-50-212

by Depuy (Ireland)

Ref 1516-50-212Model ATTUNE Knee System Cemented RP Tibial Insert

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

CE MDR

Valid until

9 Jul 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 755208 Date29 Jun 2026IssuedStatusActive expires 9 Jul 2029
United StatesGUDID listing GUDID Number10603295052050 UDI-DI Date24 Mar 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

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  • Withdrawn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 RP Tibial Insert
Model / Ref / Catalog
1516-50-212, ATTUNE Knee System Cemented RP Tibial Insert, 151650212
Primary DI / UDI-DI
10603295052050
Basic UDI-DI
0603295a002568T
FDA Product Code
NJL
EMDN Code
P090903020201 Bicompartmental primary implant mobile bearing tibial inserts
GMDN Term
Tibial insert
Device Class
Class III
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Tibial insert

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

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