Skip to content

Endo-Model Standard Knee Prosthesis System 15-2975/12

by WALDEMAR LINK GmbH & Co. KG

Ref 15-2975/12Model Centralizer, cemented, UHMWPE

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

CE MDR

Valid until

28 Sep 2028

CE MDR certificate

FDA recalls

16 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DNV MEDCERT GmbH

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 Number4026575-1-KNR-251037-YV Basic UDI-DI 04026575205943UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575205943 UDI-DI Date1 Nov 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13804GB450250207 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    7 Feb 2025
    Expires
    28 Sep 2028
    Reason
    Add device or group

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.

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
Endo-Model Standard Knee Prosthesis System
Generic Name
Knee femur stem prosthesis
Device Name
Endo-Model Knee System / LINK Endo-Model EVO Knee System
Model / Ref / Catalog
15-2975/12, Centralizer, cemented, UHMWPE
Primary DI / UDI-DI
04026575205943
Basic UDI-DI
4026575-1-KNR-251037-YV
510(k) Number
FDA Product Code
LWJ, JDI, LZO, KRO
EMDN Code
P09098004 Knee prostheses centralisers
GMDN Term
Knee femur stem prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3360, 888.3350, 888.3353, 888.3510
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

Related devices

Category: Knee femur stem prosthesis

Cleared under the same submission (K151008)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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

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