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Dynamic Axial Fixator 1

by Orthofix, Inc. 43 variants

Ref 11012Model ORTHOPEDIC INSTRUMENTS

Dynamic Axial Fixator 1 (11012) is a device classified as Class IIa in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436Instrum2a269P), cleared under FDA 510(k) K955848 on 20 Mar 1996 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 18032568032048), active as of 7 Nov 2026. 23 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

23 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K955848

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 Number805050436Instrum2a269P Basic UDI-DI 18032568032048UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18032568032048 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK955848 Date20 Mar 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436Instrum2a269P registered 22 Oct 2026 Active
  • FDA 510(k) K955848 decided 20 Mar 1996 Active
  • FDA GUDID UDI-DI 18032568032048 listed 16 Sep 2016 Listed

Recalls

23 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0390-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0375-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0382-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0383-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0374-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0373-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0393-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0379-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0391-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0384-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0381-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0392-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0377-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0378-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0387-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0386-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0385-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0376-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0380-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0388-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0389-2020 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.

  • 2 recalls, same reason

    • Terminated Z-1435-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010
    • Terminated Z-1434-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010

    During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.

Timeline

26 dated events

  1. Recall initiated FDA recalls Z-0377-2020
  2. Recall initiated FDA recalls Z-0378-2020
  3. Recall initiated FDA recalls Z-0387-2020
  4. Recall initiated FDA recalls Z-0386-2020
  5. Recall initiated FDA recalls Z-0385-2020
  6. Recall initiated FDA recalls Z-0376-2020
  7. Recall initiated FDA recalls Z-0380-2020
  8. Recall initiated FDA recalls Z-0388-2020
  9. Recall initiated FDA recalls Z-0389-2020
  10. Registered EUDAMED 805050436Instrum2a269P

16 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
Dynamic Axial Fixator GUDID
Generic name
Fluted surgical drill bit, single-use, non-sterile
Model / Ref / Catalog
ORTHOPEDIC INSTRUMENTS, 11012, 1
Description
CANNULATED DRILL BIT KIT L 280 MM D 4.8 MM 2.2 MM HOLE
Primary DI / UDI-DI
18032568032048
Basic UDI-DI
805050436Instrum2a269P
510(k) Number
FDA product code
JDW
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Fluted surgical drill bit, single-use, non-sterile
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4.8 Millimeter
Length — 280 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ORTHOPEDIC INSTRUMENTS
11012
GUDID
1
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: Fluted surgical drill bit, single-use, non-sterile

Cleared under the same submission (K955848)

and 8 more cleared under K955848

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER.

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)