# K081401: Mayfield MR/X-Ray Skull Clamp

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Oct 8, 2008 after 142 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050319 (2005). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050319: Mayfield MR/CT Skull Clamp, Model 4-0-a-1104, Integra Lifesciences Corp. (2005) Summary page 1.

## Most influential descendants
- K103493: Head Fiation Device (HFD 100) (2011), 2 descendants of its own
- 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

## Indications for use
The MAYFIELD® MR/X-Ray Skull clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Arm X-ray, and digital subtraction techniques.

Source page: https://510kreport.com/device/K081401
Methodology: https://510kreport.com/methodology