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Galaxy Fixation System 1

by Orthofix SRL 7 variants

Ref 19955Model Reusable Surgical Instrument intended to support the implantation of screws, nails or plates during orthopedic and traumatology surgery

Galaxy Fixation System 1 (19955) is a device classified as Class I in the EU and Class II in the US made by Orthofix SRL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436RSIImpl1rMTLNQ), cleared under FDA 510(k) K113770 on 4 Sep 2012 and listed in FDA GUDID since 24 Apr 2018 (UDI-DI 18033509859946), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436RSIImpl1rMTLNQ Basic UDI-DI 18033509859946UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18033509859946 UDI-DI Date24 Apr 2018ListedStatusListed 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 805050436RSIImpl1rMTLNQ registered 22 Oct 2026 Active
  • FDA 510(k) K113770 decided 4 Sep 2012 Active
  • FDA GUDID UDI-DI 18033509859946 listed 24 Apr 2018 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 805050436RSIImpl1rMTLNQ

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
Orthofix Surgical Instruments EUDAMED
Galaxy Fixation System GUDID
Generic name
Orthopaedic trocar blade, reusable
Model / Ref / Catalog
Reusable Surgical Instrument intended to support the implantation of screws, nails or plates during orthopedic and traumatology surgery, 19955, 1
Primary DI / UDI-DI
18033509859946
Basic UDI-DI
805050436RSIImpl1rMTLNQ
510(k) Number
FDA product code
KTT
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Orthopaedic trocar blade, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Italy
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 trocar blade, reusable

Cleared under the same submission (K113770)

and 8 more cleared under K113770

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)