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MP Reconstruction System - Instruments 134-700/04

by WALDEMAR LINK GmbH & Co. KG EUDAMEDGUDID

Active European Union and United States

Ref 172-902/14Model Hip stem, cemented, CoCrMo, anatomical

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HSR-050002-Y6 Basic UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575342273 UDI-DIDate20 Dec 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13792GB450240723 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0482
    Issued
    23 Jul 2024
    Expires
    22 Jul 2029

Recalls

21 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-2073-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2064-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2074-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2061-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2060-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2065-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2063-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2079-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2075-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2062-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2066-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2069-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2068-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2080-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2076-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2078-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2072-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2071-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2070-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2077-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)
    • Terminated Z-2067-2013 FDA Class II initiated 16 Jul 2013 via K955296, on the same 510(k)

    The trial stems were manufactured using the wrong design.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID

Trade Name
MP Reconstruction System - Instruments
MP Reconstruction Prosthesis
Generic Name
Medullary canal orthopaedic reamer, rigid
Revision uncoated hip femur prosthesis
Model / Ref / Catalog
172-902/14, Hip stem, cemented, CoCrMo, anatomical, 134-700/04
Primary DI / UDI-DI
04026575342273, 04026575081318
Basic UDI-DI
4026575-1-HSR-050002-Y6
510(k) Number
FDA Product Code
HTO, LZO, JDI
EMDN Code
P090804030102 Revision cemented femoral stems, with modular neck
GMDN Term
Medullary canal orthopaedic reamer, rigid
Revision uncoated hip femur prosthesis
Device Class
Class III EUDAMED
Class I GUDID
Class II GUDID
Regulation Number
888.4540, 888.3353, 888.3350
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class I
Class II
SterileEUDAMED
Yes
GUDID
Yes
No
ImplantableEUDAMED
Yes
GUDID
Yes
No

Related devices

Category: Medullary canal orthopaedic reamer, rigid

Other devices from WALDEMAR LINK GmbH & Co. KG

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

Properties

  • Sterile YesEUDAMEDGUDIDNoGUDID
  • Single Use NoGUDIDYesGUDID
  • Implantable YesEUDAMEDGUDIDNoGUDID
  • CMR Substance
  • Prescription Use YesGUDIDNoGUDID
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (15)

  • 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
  • Serial Number: No