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Delta Xtend 130716000

by Depuy (Ireland)

Ref 1307-16-000Model DELTA XTEND Modular Humeral Stem

Delta Xtend 130716000 is a device classified as Class III in the EU and Class II in the US made by Depuy (Ireland), registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0603295a000918K) with CE/MDR certificate MDR 743997 valid until 17 Jul 2028, cleared under FDA 510(k) K192855 on 24 Feb 2020 (3 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295027270), active as of 25 Oct 2026. 2 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

17 Jul 2028

CE MDR certificate

FDA recalls

None ongoing

2 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K192855

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 743997 Date13 Jul 2026IssuedStatusActive expires 17 Jul 2028
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192855 Date24 Feb 2020DecidedStatusActive
United StatesGUDID listing GUDID Number10603295027270 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0603295a000918K registered 28 May 2026 Active· +1 more in the status table
  • FDA 510(k) K192855 decided 24 Feb 2020 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10603295027270 listed 24 Sep 2015 Listed

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

2 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.

Timeline

10 dated events

  1. Cleared FDA 510(k) K071379
  2. Cleared FDA 510(k) K120174
  3. Listed FDA GUDID 10603295027270
  4. Recall initiated FDA recalls Z-0833-2018
  5. Recall initiated FDA recalls Z-0834-2018
  6. Cleared FDA 510(k) K192448
  7. Cleared FDA 510(k) K192855
  8. Registered EUDAMED 0603295a000918K
  9. Certificate issued EUDAMED MDR 743997
  10. Certificate expires EUDAMED MDR 743997

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
Delta Xtend
Generic name
Total reverse shoulder prosthesis
Device name
DELTA XTEND Modular Humeral Stem
Model / Ref / Catalog
DELTA XTEND Modular Humeral Stem EUDAMED
1307-16-000 EUDAMED
130716000 GUDID
Primary DI / UDI-DI
10603295027270
Basic UDI-DI
0603295a000918K
510(k) Number
FDA product code
PHX, HSD, KWS
EMDN code
P0901040202 Shoulder prostheses modular stems
GMDN term
Total reverse shoulder prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3690
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DELTA XTEND Modular Humeral Stem
1307-16-000
GUDID
130716000
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Total reverse shoulder prosthesis

Cleared under the same submission (K071379)

and 5 more cleared under K071379

Cleared under the same submission (K120174)

and 8 more cleared under K120174

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES MODULAR STEMS.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)