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Gemini SL 318-004/00

by WALDEMAR LINK GmbH & Co. KG

Ref 318-004/00Model Stem security screw set, TiNbN coating, CoCrMo

Gemini SL 318-004/00 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 25 Jun 2026 (Basic UDI-DI 4026575-1-KNP-200032-UL) with CE/MDR certificate 13803GB450251029 valid until 17 Jan 2029, cleared under FDA 510(k) K212742 on 16 Sep 2021 (1 earlier submission) and listed in FDA GUDID since 1 Oct 2021 (UDI-DI 04026575195336), active as of 24 Oct 2026. 6 FDA recalls are linked to it.

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

CE MDR 510(k)

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

510(k) K212742

+1 more

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-KNP-200032-UL Basic UDI-DI 04026575195336UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575195336 UDI-DI Date1 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK212742 Date16 Sep 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4026575-1-KNP-200032-UL registered 25 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K212742 decided 16 Sep 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04026575195336 listed 1 Oct 2021 Listed

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.

Timeline

28 dated events

  1. Recall initiated FDA recalls Z-1544-2023
  2. Recall initiated FDA recalls Z-1547-2023
  3. Recall initiated FDA recalls Z-1542-2023
  4. Recall initiated FDA recalls Z-1539-2023
  5. Recall initiated FDA recalls Z-1546-2023
  6. Recall initiated FDA recalls Z-2410-2024
  7. Recall initiated FDA recalls Z-2411-2024
  8. Certificate issued EUDAMED 13803GB450251029
  9. Registered EUDAMED 4026575-1-KNP-200032-UL
  10. Certificate expires EUDAMED 13803GB450251029

18 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
Gemini SL
Generic name
Coated knee tibia prosthesis
Device name
GEMINI SL Total Knee System
Model / Ref / Catalog
318-004/00, Stem security screw set, TiNbN coating, CoCrMo
Primary DI / UDI-DI
04026575195336
Basic UDI-DI
4026575-1-KNP-200032-UL
510(k) Number
FDA product code
JWH
EMDN code
P09098099 Knee prostheses - accessories - other
GMDN term
Coated knee tibia prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3560
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

Related devices

Category: Coated knee tibia prosthesis

Cleared under the same submission (K182872)

and 8 more cleared under K182872

Cleared under the same submission (K212742)

and 8 more cleared under K212742

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)