# K120633: Mayfield Skull Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: May 24, 2012 after 84 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050319 (2005). 3 ancestors in all.
2 later devices descend 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)
- K090506: Mayfield Infinity XR2 Skull Clamp, Model a-2114, Integra LifeSciences Corporation (2009) Summary page 1.

## Most influential descendants
- K142238: MAYFIELD Skull Clamp (2014), 1 descendant of its own
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 descendants of its own

## Recalls of this device
- Aug 29, 2013 · Class II · Z-0210-2014: An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the com
- Nov 5, 2012 · Class II · Z-0559-2013: An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite

## 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 skull fixation is necessary.

Source page: https://510kreport.com/device/K120633
Methodology: https://510kreport.com/methodology