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Fx Solutions 926-1013

by Fx Solutions

Part of a family of 19 devices: see the family page

Ref 926-1013

Fx Solutions 926-1013 is a device classified as Class IIa in the EU and Class II in the US made by Fx Solutions, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 37010373TRIAHDF7), cleared under FDA 510(k) K123814 on 13 Aug 2013 and listed in FDA GUDID since 6 Dec 2016 (UDI-DI 03701037303610), active as of 25 Oct 2026. 2 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123814

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 Number37010373TRIAHDF7 Basic UDI-DI 03701037303610UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037303610 UDI-DI Date6 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123814 Date13 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 37010373TRIAHDF7 registered 22 Jun 2026 Active
  • FDA 510(k) K123814 decided 13 Aug 2013 Active
  • FDA GUDID UDI-DI 03701037303610 listed 6 Dec 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2469-2018 FDA Class II initiated 4 Jun 2018
    • Terminated Z-2468-2018 FDA Class II initiated 4 Jun 2018

    Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

Timeline

5 dated events

  1. Cleared FDA 510(k) K123814
  2. Listed FDA GUDID 03701037303610
  3. Recall initiated FDA recalls Z-2469-2018
  4. Recall initiated FDA recalls Z-2468-2018
  5. Registered EUDAMED 37010373TRIAHDF7

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  • Withdrawn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
Fx Solutions
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Trial Head
Model / Ref / Catalog
926-1013
Primary DI / UDI-DI
03701037303610
Basic UDI-DI
37010373TRIAHDF7
Direct marketing DI
03701037303610
510(k) Number
FDA product code
HSD, KWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3690, 888.3650
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Orthopaedic surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K111097)

and 8 more cleared under K111097

Cleared under the same submission (K123814)

and 8 more cleared under K123814

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Sterilise before use
  • Reusable
  • Lot / batch number
Other properties (22, all answered No)