# K021604: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Jul 29, 2002 after 74 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923789 (1993). 1 ancestor in all.
7 later devices descend from it; 2 cite 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)
- K923789: Mayfield Adult Disposable Skull Pin, Ohio Medical Instrument Co., Inc. (1993) Summary page 1.

## Most influential descendants
- K053045: Modification to:  Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 (2005), 6 descendants of its own
- K071458: Mayfield Radiolucent Disposable Skull Pins (2007), 5 descendants of its own
- 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

## Recalls of this device
- Jun 29, 2004 · Not classified · Z-1221-04: Skull pins, which fractured below device specifications during QC testing, were distributed.

## Indications for use
The MAYFIELD@Radiolucent Skull Pins A-2020 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 Skull Pins A-2020 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/K021604
Methodology: https://510kreport.com/methodology