# K142238: MAYFIELD Skull Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Nov 24, 2014 after 103 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: 3 generations back to K050319 (2005). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120633: Mayfield Skull Clamp, Integra LifeSciences Corporation (2012) Summary page 4.

## Most influential descendants
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 descendants of its own

## Indications for use
The MAYFIELD 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 skeletal fixation is necessary.

Source page: https://510kreport.com/device/K142238
Methodology: https://510kreport.com/methodology