# K103493: Head Fiation Device (HFD 100)

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Mar 11, 2011 after 102 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K944964 (1995). 56 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 59 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081401: Mayfield MR/X-Ray Skull Clamp, Integra Lifesciences Corp. (2008) Summary page 2.
- K072208: Mayfield Disposable and Reusable Titanium Skull Pins, Integra LifeSciences Corporation (2007) Summary page 1.
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components, Pro-Med Instruments GmbH (2007) Summary page 1.

## Most influential descendants
- K141950: HFD100 Rocker Arm Accessory (2014), 0 descendants of its own
- K113748: Imris MR/X-Ray Head Fixation Device (HFD) (2012), 0 descendants of its own

## Recalls of this device
- Dec 8, 2025 · Class II · Z-1034-2026: 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 m
- Feb 17, 2022 · Class II · Z-0934-2022: 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 withi
- Aug 14, 2017 · Class II · Z-3211-2017: incorrect thread on thumbscrews

## Indications for use
The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

Source page: https://510kreport.com/device/K103493
Methodology: https://510kreport.com/methodology