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Gemini SL 318-207/25

by WALDEMAR LINK GmbH & Co. KG

Ref 318-207/25Model Femoral component, TiNbN coating, cemented, CoCrMo, fixed bearing CR / mobile bearing

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

CE MDR

Valid until

17 Jan 2029

CE MDR certificate

FDA recalls

22 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-KNP-200002-U5 Basic UDI-DI 04026575411870UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575411870 UDI-DI Date17 Apr 2019ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13803GB450251029 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    29 Oct 2025
    Expires
    17 Jan 2029
    Reason
    Add device or group

Recalls

22 recalls · 22 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2410-2024 FDA Class II initiated 22 May 2024
    • Ongoing Z-2411-2024 FDA Class II initiated 22 May 2024

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

  • 16 recalls, same reason

    • Ongoing Z-1543-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1549-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1551-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1552-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1540-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1548-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1550-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1553-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1554-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1545-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1541-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1544-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1547-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1542-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1539-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742
    • Ongoing Z-1546-2023 FDA Class II initiated 21 Mar 2023 on shared 510(k) K212742

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

  • 4 recalls, same reason

    • Ongoing Z-1380-2022 FDA Class II initiated 24 May 2022
    • Ongoing Z-1377-2022 FDA Class II initiated 24 May 2022
    • Ongoing Z-1379-2022 FDA Class II initiated 24 May 2022
    • Ongoing Z-1378-2022 FDA Class II initiated 24 May 2022

    There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

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
Gemini SL
Generic Name
Coated knee femur prosthesis
Device Name
GEMINI SL Total Knee System
Model / Ref / Catalog
318-207/25, Femoral component, TiNbN coating, cemented, CoCrMo, fixed bearing CR / mobile bearing
Primary DI / UDI-DI
04026575411870
Basic UDI-DI
4026575-1-KNP-200002-U5
510(k) Number
FDA Product Code
JWH
EMDN Code
P0909030101 Bicompartmental primary implant cemented femoral components
GMDN Term
Coated knee femur prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560
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: Coated knee femur prosthesis

Cleared under the same submission (K182872)

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Cleared under the same submission (K212742)

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Other devices from WALDEMAR LINK GmbH & Co. KG

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Properties

  • Sterile
  • Single Use
  • Implantable
  • CMR Substance
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (17)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No