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Synthes Mandible External Fixator

by Synthes (Usa) 2 variants

510(k) K050378

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050378 Date15 Mar 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1009-2015 FDA Class II initiated 17 Oct 2014

    Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.

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  • Withdrawn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
MQN
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Synthes Mandible External Fixator is a mechanical orthopedic system designed for the stabilization of maxillofacial fractures. It provides rigid fixation for bone and is indicated for the treatment of severe open mandibular fractures, highly comminuted closed fractures, nonunions, delayed unions, fractures associated with infections, and tumor resections.

This device is applied by surgeons in a clinical or surgical setting and is designed for use in the MR environment. Components include adjustable parallel pin clamps, 4.0/2.5 Schanz screws, 2.0 mm K-wires, and 4.0 mm titanium rods. The device has received FDA 510(k) clearance under K050378.

Other devices from Synthes (Usa)

See all devices from Synthes (Usa) →

Questions

AI-generated answers, 25 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 clinical conditions is the Synthes Mandible External Fixator used to treat?

    This system is indicated for the stabilization of maxillofacial fractures. Specifically, it is used for severe open mandibular fractures, highly comminuted closed fractures, nonunions, delayed unions, fractures associated with infections, and tumor resections.

  • Can this device be used in an MRI environment?

    Yes, the Synthes Mandible External Fixator is designed for use in the MR environment, allowing for necessary imaging while the device is in place for fracture stabilization.

  • What components are included in the fixator system?

    The system consists of several specialized components to provide rigid bone fixation, including adjustable parallel pin clamps, 4.0/2.5 Schanz screws, 2.0 mm K-wires, and 4.0 mm titanium rods.

  • What is the regulatory status of this device?

    The Synthes Mandible External Fixator has received FDA 510(k) clearance under K050378. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.