# K113748: Imris MR/X-Ray Head Fixation Device (HFD)

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Mar 23, 2012 after 93 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K944964 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103493: Head Fiation Device (HFD 100), Imris, Inc. (2011) Summary page 1.
- K081401: Mayfield MR/X-Ray Skull Clamp, Integra Lifesciences Corp. (2008) Summary page 1.
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components, Pro-Med Instruments GmbH (2007) Summary page 1.

## Recalls of this device
- Jun 26, 2019 · Class II · Z-0163-2020: Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning 

## Indications for use
The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C-Arm X-ray angiography.

Source page: https://510kreport.com/device/K113748
Methodology: https://510kreport.com/methodology