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Head Fixation Device HFD100

by IMRIS Imaging, Inc. 2 variants

Head Fixation Device HFD100 is a Class II device made by IMRIS Imaging, Inc., cleared under FDA 510(k) K103493 on 11 Mar 2011 and listed in FDA GUDID since 28 Feb 2017 (UDI-DI 00857534006394), active as of 22 Oct 2026. 3 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

1 ongoing

This device is named in the recall

Documents

510(k) K103493

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857534006394 UDI-DI Date28 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103493 Date11 Mar 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103493 decided 11 Mar 2011 Active
  • FDA GUDID UDI-DI 00857534006394 listed 28 Feb 2017 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1034-2026 FDA Class II initiated 8 Dec 2025

    Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

    • Terminated Z-0934-2022 FDA Class II initiated 17 Feb 2022

    Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.

    • Terminated Z-3211-2017 FDA Class II initiated 14 Aug 2017

    incorrect thread on thumbscrews

Timeline

5 dated events

  1. Cleared FDA 510(k) K103493
  2. Listed FDA GUDID 00857534006394
  3. Recall initiated FDA recalls Z-3211-2017
  4. Recall initiated FDA recalls Z-0934-2022
  5. Recall initiated FDA recalls Z-1034-2026

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Skull clamp
Model / reference
HFD100
Description
Head Fixation Device HFD100 , 113803-600
Primary DI / UDI-DI
00857534006394
510(k) Number
FDA product code
HBL
GMDN term
Skull clamp
Device class
Class II
Regulation number
882.4460
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Skull clamp

Cleared under the same submission (K103493)

Other devices from IMRIS Imaging, Inc.

See all devices from IMRIS Imaging, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)