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Galaxy Fixation System 1

by Orthofix, Inc. 7 variants

Ref 99-93100Model BONE FIXATION SCREWS, TENDONS AND LIGAMENTS SCREWS

Galaxy Fixation System 1 (99-93100) is a device classified as Class IIb in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436Screw2bNAC26G3V), cleared under FDA 510(k) K113770 on 4 Sep 2012 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 18033509859878), active as of 7 Nov 2026. 13 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

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113770

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436Screw2bNAC26G3V Basic UDI-DI 18033509859878UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18033509859878 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113770 Date4 Sep 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436Screw2bNAC26G3V registered 22 Oct 2026 Active
  • FDA 510(k) K113770 decided 4 Sep 2012 Active
  • FDA GUDID UDI-DI 18033509859878 listed 1 Sep 2015 Listed

Recalls

13 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2732-2026 FDA Class II initiated 10 Jun 2026
    • Ongoing Z-2729-2026 FDA Class II initiated 10 Jun 2026
    • Ongoing Z-2731-2026 FDA Class II initiated 10 Jun 2026
    • Ongoing Z-2730-2026 FDA Class II initiated 10 Jun 2026

    Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

  • 9 recalls, same reason

    • Terminated Z-0400-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0401-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0399-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0398-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0397-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0402-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0395-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0394-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0396-2020 FDA Class II initiated 27 Sep 2018

    As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-0397-2020
  2. Recall initiated FDA recalls Z-0402-2020
  3. Recall initiated FDA recalls Z-0395-2020
  4. Recall initiated FDA recalls Z-0394-2020
  5. Recall initiated FDA recalls Z-0396-2020
  6. Recall initiated FDA recalls Z-2732-2026
  7. Recall initiated FDA recalls Z-2729-2026
  8. Recall initiated FDA recalls Z-2731-2026
  9. Recall initiated FDA recalls Z-2730-2026
  10. Registered EUDAMED 805050436Screw2bNAC26G3V

6 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
Implantable Devices for External Fixation and Related Instruments EUDAMED
Galaxy Fixation System GUDID
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
BONE FIXATION SCREWS, TENDONS AND LIGAMENTS SCREWS, 99-93100, 1
Primary DI / UDI-DI
18033509859878
Basic UDI-DI
805050436Screw2bNAC26G3V
510(k) Number
FDA product code
KTT
EMDN code
P09120402 Screws
GMDN term
Orthopaedic bone wire
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BONE FIXATION SCREWS, TENDONS AND LIGAMENTS SCREWS
99-93100
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K113770)

and 8 more cleared under K113770

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)