# K071458: Mayfield Radiolucent Disposable Skull Pins

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Jun 13, 2007 after 19 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 K923789 (1993). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021604: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020, Ohio Medical Instrument Co., Inc. (2002) Summary page 1.
- K053045: Modification to:  Mayfield Radiolucent Skull Pins, Model 4-0-a-2020, Integra LifeSciences Corporation (2005). Our reading of the summary gave K050345, FDA’s number for Cie Foldaway Wheelchair (Carlsbad International Export, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mayfield® Radiolucent Skull Pins”.

## Most influential descendants
- K072208: Mayfield Disposable and Reusable Titanium Skull Pins (2007), 4 descendants of its own
- K103493: Head Fiation Device (HFD 100) (2011), 2 descendants of its own
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 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® Radiolucent Disposable Skull Pins are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used. The MAYFIELD® Radiolucent Disposable Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MR imaging of the patient is used.

Source page: https://510kreport.com/device/K071458
Methodology: https://510kreport.com/methodology