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Orthofix Modulsystem 1

by Orthofix, Inc. 433 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

23 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Overview

The SMALL BLUE D.A.F. is an innovative external orthopaedic fixation system designed to stabilize fractured bones and promote treatment and healing, particularly for long bones such as the femur, tibia, and humerus, fractures of the foot and ankle, joint fusions, and limb lengthening. This single-use device features a modular design with a fixator framework, clamps, rods, rings, pins, bolts, and nuts, along with reusable instrumentation. It is used in commercial distribution by ORTHOFIX SRL and has been updated to the latest public version.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18032568035544 UDI-DI Date19 Apr 2018ListedStatusListed GUDID: in commercial distribution

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Orthofix Modulsystem
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
1, 30004
Primary DI / UDI-DI
18032568035544
510(k) Number
FDA Product Code
JDW
GMDN Term
External orthopaedic fixation system noninvasive component, single-use
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K955848)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No