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Gemini SL 318-234/12

by WALDEMAR LINK GmbH & Co. KG

Ref 318-234/12Model Articulating surface, UHMWPE, fixed bearing CR

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 23 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

510(k) K182872

FDA submission, from GUDID

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-200019-UX Basic UDI-DI 04026575373062UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575373062 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

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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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, polyethylene
Device name
GEMINI SL Total Knee System
Model / Ref / Catalog
318-234/12, Articulating surface, UHMWPE, fixed bearing CR
Primary DI / UDI-DI
04026575373062
Basic UDI-DI
4026575-1-KNP-200019-UX
510(k) Number
FDA product code
JWH
EMDN code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN term
Uncoated knee tibia prosthesis, polyethylene
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: Uncoated knee tibia prosthesis, polyethylene

Cleared under the same submission (K182872)

Show all (12)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (19)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No