# K050319: Mayfield MR/CT Skull Clamp, Model 4-0-a-1104

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Mar 31, 2005 after 50 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mayfield® Radiolucent Skull Clamp: named in the summary without a submission number

## Most influential descendants
- K090506: Mayfield Infinity XR2 Skull Clamp, Model a-2114 (2009), 5 descendants of its own
- K081401: Mayfield MR/X-Ray Skull Clamp (2008), 3 descendants of its own
- K120633: Mayfield Skull Clamp (2012), 2 descendants of its own
- K103493: Head Fiation Device (HFD 100) (2011), 2 descendants of its own
- K142238: MAYFIELD Skull Clamp (2014), 1 descendant of its own

## Indications for use
The Mayfield MR/CT 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 intracperative CT and MR imaging, C-Arm x-ray, and digital subtraction techniques.

Source page: https://510kreport.com/device/K050319
Methodology: https://510kreport.com/methodology