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Prefix Fixator 1

by Orthofix, Inc. 26 variants

Prefix Fixator 1 (99-92504US) is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K955848 on 20 Mar 1996 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 18033509856174), active as of 23 Oct 2026. 23 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

None ongoing

23 closed

Documents

510(k) K955848

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18033509856174 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955848 Date20 Mar 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955848 decided 20 Mar 1996 Active
  • FDA GUDID UDI-DI 18033509856174 listed 1 Sep 2015 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

25 dated events

  1. Recall initiated FDA recalls Z-0392-2020
  2. Recall initiated FDA recalls Z-0377-2020
  3. Recall initiated FDA recalls Z-0378-2020
  4. Recall initiated FDA recalls Z-0387-2020
  5. Recall initiated FDA recalls Z-0386-2020
  6. Recall initiated FDA recalls Z-0385-2020
  7. Recall initiated FDA recalls Z-0376-2020
  8. Recall initiated FDA recalls Z-0380-2020
  9. Recall initiated FDA recalls Z-0388-2020
  10. Recall initiated FDA recalls Z-0389-2020

15 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
Prefix Fixator
Generic name
External orthopaedic fixation system, single-use, sterile
Model / Ref / Catalog
1, 99-92504US
Primary DI / UDI-DI
18033509856174
510(k) Number
FDA product code
JDW
GMDN term
External orthopaedic fixation system, single-use, sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: External orthopaedic fixation system, single-use, sterile

Cleared under the same submission (K955848)

and 8 more cleared under K955848

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)