# K072208: Mayfield Disposable and Reusable Titanium Skull Pins

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Sep 7, 2007 after 30 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: 9 generations back to K944964 (1995). 53 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932860: Mayfield Adult Disposable Skull Pin, Ohio Medical Instrument Co., Inc. (1993) Summary page 1.
- K071458: Mayfield Radiolucent Disposable Skull Pins, Integra LifeSciences Corporation (2007) Summary page 1.
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components, Pro-Med Instruments GmbH (2007) Summary page 1.
- (no number) MAYFIELD® Reusable Steel Skull Pins: named in the summary without a submission number

## Most influential descendants
- 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® Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD 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 MR imaging is used. The MAYFIELD® Disposable and Reusable Titanium Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used.

Source page: https://510kreport.com/device/K072208
Methodology: https://510kreport.com/methodology