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Delta Xtend 130748021

by Depuy (Ireland)

Ref 1307-48-021Model DELTA XTEND CTA Head

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

CE MDR

Valid until

17 Jul 2028

CE MDR certificate

FDA recalls

None ongoing

10 closed

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 743997 Date13 Jul 2026IssuedStatusActive expires 17 Jul 2028
United StatesGUDID listing GUDID Number10603295027690 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 743997 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    13 Jul 2026
    Expires
    17 Jul 2028
    Reason
    Change approved

Recalls

10 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0833-2018 FDA Class II initiated 31 Aug 2017
    • Terminated Z-0834-2018 FDA Class II initiated 31 Aug 2017

    The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

  • 8 recalls, same reason

    • Terminated Z-0537-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0538-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0536-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0533-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0532-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0535-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0534-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008
    • Terminated Z-0539-2009 FDA Unclassified (pre-2012) initiated 10 Jul 2008

    Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.

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  • Withdrawn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
Delta Xtend
Generic Name
Stem-fixed metallic humeral head prosthesis
Device Name
DELTA XTEND CTA Head
Model / Ref / Catalog
DELTA XTEND CTA Head EUDAMED
1307-48-021 EUDAMED
130748021 GUDID
Primary DI / UDI-DI
10603295027690
Basic UDI-DI
0603295a000848N
510(k) Number
FDA Product Code
KWS, HSD
EMDN Code
P090104010101 Epiphysary humeral components for anatomical prostheses - humeral heads
GMDN Term
Stem-fixed metallic humeral head prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3660, 888.3690
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DELTA XTEND CTA Head
1307-48-021
GUDID
130748021
Device ClassEUDAMED
Class III
GUDID
Class II

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Properties

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

Other properties (17)

  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No