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Gemini SL 318-190/14

by WALDEMAR LINK GmbH & Co. KG

Ref 318-190/14Model Tibial stem, cemented, Ti6Al4V

Gemini SL 318-190/14 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-200027-UW) with CE/MDR certificate 13803GB450251029 valid until 17 Jan 2029, cleared under FDA 510(k) K182872 on 3 Apr 2019 and listed in FDA GUDID since 17 Apr 2019 (UDI-DI 04026575089680), active as of 25 Oct 2026.

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

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

510(k) K182872

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-KNP-200027-UW Basic UDI-DI 04026575089680UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575089680 UDI-DI Date17 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182872 Date3 Apr 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4026575-1-KNP-200027-UW registered 25 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K182872 decided 3 Apr 2019 Active
  • FDA GUDID UDI-DI 04026575089680 listed 17 Apr 2019 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

Timeline

5 dated events

  1. Cleared FDA 510(k) K182872
  2. Listed FDA GUDID 04026575089680
  3. Certificate issued EUDAMED 13803GB450251029
  4. Registered EUDAMED 4026575-1-KNP-200027-UW
  5. Certificate expires EUDAMED 13803GB450251029

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  • Withdrawn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
Uncoated knee tibia prosthesis, metallic
Device name
GEMINI SL Total Knee System
Model / Ref / Catalog
318-190/14, Tibial stem, cemented, Ti6Al4V
Primary DI / UDI-DI
04026575089680
Basic UDI-DI
4026575-1-KNP-200027-UW
510(k) Number
FDA product code
JWH
EMDN code
P0909800602 Knee prostheses tibial stems
GMDN term
Uncoated knee tibia prosthesis, metallic
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

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: Uncoated knee tibia prosthesis, metallic

Cleared under the same submission (K182872)

and 8 more cleared under K182872

Similar devices in this category

Other devices filed under KNEE PROSTHESES TIBIAL 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)