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LINK Endo-Model EVO 15-4319/12

by WALDEMAR LINK GmbH & Co. KG

Ref 15-4319/12Model Modular stem, uncemented, Ti6Al4V, 3 mm offset, cylindrical (EVO)

LINK Endo-Model EVO 15-4319/12 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 5 Oct 2026 (Basic UDI-DI 4026575-1-KNR-251058-ZA) with CE/MDR certificate 13804GB450250207 valid until 28 Sep 2028, cleared under FDA 510(k) K202924 on 13 May 2021 and listed in FDA GUDID since 7 Oct 2021 (UDI-DI 04026575270620), active as of 24 Oct 2026. 11 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

28 Sep 2028

CE MDR certificate

FDA recalls

11 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DNV MEDCERT GmbH

510(k) K202924

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-KNR-251058-ZA Basic UDI-DI 04026575270620UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575270620 UDI-DI Date7 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202924 Date13 May 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4026575-1-KNR-251058-ZA registered 5 Oct 2026 Active· +1 more in the status table
  • FDA 510(k) K202924 decided 13 May 2021 Active
  • FDA GUDID UDI-DI 04026575270620 listed 7 Oct 2021 Listed

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

11 recalls · 11 ongoing · FDA

    • Ongoing Z-2541-2025 FDA Class II initiated 31 Jul 2025

    Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

  • 4 recalls, same reason

    • Ongoing Z-1702-2025 FDA Class II initiated 3 Apr 2025
    • Ongoing Z-1700-2025 FDA Class II initiated 3 Apr 2025
    • Ongoing Z-1699-2025 FDA Class II initiated 3 Apr 2025
    • Ongoing Z-1701-2025 FDA Class II initiated 3 Apr 2025

    The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

  • 3 recalls, same reason

    • Ongoing Z-1372-2025 FDA Class II initiated 14 Feb 2025
    • Ongoing Z-1374-2025 FDA Class II initiated 14 Feb 2025
    • Ongoing Z-1373-2025 FDA Class II initiated 14 Feb 2025

    A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

    • Ongoing Z-1674-2023 FDA Class II initiated 25 Apr 2023

    Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

  • 2 recalls, same reason

    • Ongoing Z-2066-2023 FDA Class II initiated 23 Dec 2022
    • Ongoing Z-2067-2023 FDA Class II initiated 23 Dec 2022

    Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-1372-2025
  2. Recall initiated FDA recalls Z-1374-2025
  3. Recall initiated FDA recalls Z-1373-2025
  4. Recall initiated FDA recalls Z-1702-2025
  5. Recall initiated FDA recalls Z-1700-2025
  6. Recall initiated FDA recalls Z-1699-2025
  7. Recall initiated FDA recalls Z-1701-2025
  8. Recall initiated FDA recalls Z-2541-2025
  9. Registered EUDAMED 4026575-1-KNR-251058-ZA
  10. Certificate expires EUDAMED 13804GB450250207

6 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
LINK Endo-Model EVO
Generic name
Knee femur stem prosthesis
Device name
Endo-Model Knee System / LINK Endo-Model EVO Knee System
Model / Ref / Catalog
15-4319/12, Modular stem, uncemented, Ti6Al4V, 3 mm offset, cylindrical (EVO)
Primary DI / UDI-DI
04026575270620
Basic UDI-DI
4026575-1-KNR-251058-ZA
510(k) Number
FDA product code
HSX, JWH, KRO, HRY
EMDN code
P0909800601, P0909800602
GMDN term
Knee femur stem prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3520, 888.3560, 888.3510, 888.3530
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: Knee femur stem prosthesis

Cleared under the same submission (K202924)

and 8 more cleared under K202924

Similar devices in this category

Other devices filed under KNEE PROSTHESES FEMORAL STEMS.

Other devices from WALDEMAR LINK GmbH & Co. KG

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

Properties

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