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Orthofix Modulsystem

by Orthofix, Inc.

510(k) K955848

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

23 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955848 Date20 Mar 1996ClearedStatusActive

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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JDW
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orthofix Modulsystem is a unilateral external fixation device comprising frames, bars, pin clamps, pins, accessories, and instruments. It is used by physicians to treat hard tissue maladies, including fractures, leg lengthening, osteotomies, and arthrodesis.

The Orthofix Modulsystem is supplied with various components and is classified as a class 2 device with a product code of JDW. It has been found to be substantially equivalent and has an FDA 510(k) number of K955848, with a decision date of 1996-03-20.

Other devices from Orthofix, Inc.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Orthofix Modulsystem used for?

    The Orthofix Modulsystem is used by physicians to treat hard tissue maladies, including fractures, leg lengthening, osteotomies, and arthrodesis, by providing external fixation and support.

  • How is the Orthofix Modulsystem supplied?

    The Orthofix Modulsystem is supplied with various components, including frames, bars, pin clamps, pins, accessories, and instruments, to provide a comprehensive external fixation system.

  • Is the Orthofix Modulsystem a single-use or reusable device?

    The device data does not specify whether the Orthofix Modulsystem is single-use or reusable, but it is classified as a class 2 device with a product code of JDW.

  • What is the regulatory status of the Orthofix Modulsystem?

    The Orthofix Modulsystem has been found to be substantially equivalent and has an FDA 510(k) number of K955848, with a decision date of 1996-03-20.