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Megasystem C 15-8504/35

by WALDEMAR LINK GmbH & Co. KG

Ref 15-8504/35Model Neck segment, uncemented, Ti6Al4V, CoCrMo

Megasystem C 15-8504/35 is a device classified as Class III in the EU and Class II in the US made by WALDEMAR LINK GmbH & Co. KG, registered in EUDAMED on 30 Aug 2026 (Basic UDI-DI 4026575-1-KNR-253003-YQ), cleared under FDA 510(k) K151008 on 26 Aug 2015 and listed in FDA GUDID since 1 Nov 2015 (UDI-DI 04026575352678), active as of 7 Nov 2026. 14 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

16 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151008

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-KNR-253003-YQ Basic UDI-DI 04026575352678UDI-DIDate30 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575352678 UDI-DI Date1 Nov 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151008 Date26 Aug 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4026575-1-KNR-253003-YQ registered 30 Aug 2026 Active
  • FDA 510(k) K151008 decided 26 Aug 2015 Active
  • FDA GUDID UDI-DI 04026575352678 listed 1 Nov 2015 Listed

Recalls

16 recalls · 16 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-1512-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1513-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1518-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1516-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1522-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1521-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1520-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1519-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1517-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1515-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1523-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1511-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1514-2026 FDA Class II initiated 12 Jan 2026

    The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

    • Ongoing Z-0890-2026 FDA Class II initiated 10 Nov 2025

    The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

  • 2 recalls, same reason

    • Ongoing Z-2410-2024 FDA Class II initiated 22 May 2024 on shared 510(k) K151008
    • Ongoing Z-2411-2024 FDA Class II initiated 22 May 2024 on shared 510(k) K151008

    Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-1522-2026
  2. Recall initiated FDA recalls Z-1521-2026
  3. Recall initiated FDA recalls Z-1520-2026
  4. Recall initiated FDA recalls Z-1519-2026
  5. Recall initiated FDA recalls Z-1517-2026
  6. Recall initiated FDA recalls Z-1515-2026
  7. Recall initiated FDA recalls Z-1523-2026
  8. Recall initiated FDA recalls Z-1511-2026
  9. Recall initiated FDA recalls Z-1514-2026
  10. Registered EUDAMED 4026575-1-KNR-253003-YQ

9 earlier events are in the sections above.

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
Megasystem C
Generic name
Uncoated hip femur prosthesis, modular
Device name
Megasystem-C Tumor and Revision System
Model / Ref / Catalog
15-8504/35, Neck segment, uncemented, Ti6Al4V, CoCrMo
Primary DI / UDI-DI
04026575352678
Basic UDI-DI
4026575-1-KNR-253003-YQ
510(k) Number
FDA product code
KRO, LZO, JDI, LWJ
EMDN code
P090804030201 Revision uncemented femoral stems, with fixed neck
GMDN term
Uncoated hip femur prosthesis, modular
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3510, 888.3353, 888.3350, 888.3360
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Uncoated hip femur prosthesis, modular

Cleared under the same submission (K151008)

and 8 more cleared under K151008

Similar devices in this category

Other devices filed under REVISION UNCEMENTED FEMORAL STEMS, WITH FIXED NECK.

Other devices from WALDEMAR LINK GmbH & Co. KG

See all devices from WALDEMAR LINK GmbH & Co. KG →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Serial number
  • Expiration date
Other properties (18, all answered No)