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Galaxy Fixation System 1

by Orthofix SRL 29 variants

Galaxy Fixation System 1 (19965) is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K113770 on 4 Sep 2012 and listed in FDA GUDID since 24 Apr 2018 (UDI-DI 18033509859960), active as of 12 Nov 2026. 13 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

510(k) K113770

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18033509859960 UDI-DI Date24 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113770 Date4 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113770 decided 4 Sep 2012 Active
  • FDA GUDID UDI-DI 18033509859960 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

15 dated events

  1. Recall initiated FDA recalls Z-0398-2020
  2. Recall initiated FDA recalls Z-0397-2020
  3. Recall initiated FDA recalls Z-0402-2020
  4. Recall initiated FDA recalls Z-0395-2020
  5. Recall initiated FDA recalls Z-0394-2020
  6. Recall initiated FDA recalls Z-0396-2020
  7. Recall initiated FDA recalls Z-2732-2026
  8. Recall initiated FDA recalls Z-2729-2026
  9. Recall initiated FDA recalls Z-2731-2026
  10. Recall initiated FDA recalls Z-2730-2026

5 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Galaxy Fixation System
Generic name
Orthopaedic trocar blade, reusable
Model / Ref / Catalog
1, 19965
Primary DI / UDI-DI
18033509859960
510(k) Number
FDA product code
KTT
GMDN term
Orthopaedic trocar blade, reusable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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 Orthopaedic trocar blade, reusable.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)