510(k) · Cleared

Recalled · 2004

Mayfield Radiolucent Skull Pins, Model 4-0-a-2020

K021604510(k) TraditionalCleared Jul 29, 200274-day reviewClass II21 CFR 882.4460Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ohio Medical Instrument Co., Inc. · HBL Holder, Head, Neurosurgical (Skull Clamp)

Cleared on Jul 29, 2002 as substantially equivalent to K923789 (Ohio Medical Instrument Co., Inc., 1993) after a 74-day review. Its family tree reaches back 1 generation to 1993. 7 later devices descend from it. It has been recalled once.

Decided: Jul 29, 2002
Review: 74 days
Class: Class II
Product code: HBL
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K923789 (1993). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK923789 Mayfield Adult Disposable Skull PinOhio Medical Instrument Co., Inc. · 1993
This deviceK021604 Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Ohio Medical Instrument Co., Inc. · 2002
Descendant · cites it directly · 6 of its ownK053045 Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Integra LifeSciences Corporation · 2005
Descendant · cites it directly · 5 of its ownK071458 Mayfield Radiolucent Disposable Skull PinsIntegra LifeSciences Corporation · 2007
Descendant · 2 generations on · 4 of its ownK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
Descendant · 3 generations on · 2 of its ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
Descendant · 3 generations on · 0 of its ownK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005high 2 (2007) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all

K053045Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Integra LifeSciences Corporation · 2005 · cites it directly6descendants
K071458Mayfield Radiolucent Disposable Skull PinsIntegra LifeSciences Corporation · 2007 · cites it directly5descendants
K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007 · 2 generations on4descendants
K103493Head Fiation Device (HFD 100)Imris, Inc. · 2011 · 3 generations on2descendants
K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923789	Mayfield Adult Disposable Skull Pin	Ohio Medical Instrument Co., Inc.	1993	—
0 (this device)	K021604	Mayfield Radiolucent Skull Pins, Model 4-0-a-2020	Ohio Medical Instrument Co., Inc.	2002	—
+1	K053045	Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020	Integra LifeSciences Corporation	2005	—
+1	K071458	Mayfield Radiolucent Disposable Skull Pins	Integra LifeSciences Corporation	2007	—
+2	K072208	Mayfield Disposable and Reusable Titanium Skull Pins	Integra LifeSciences Corporation	2007	—
+3	K103493	Head Fiation Device (HFD 100)	Imris, Inc.	2011	3
+3	K250423	mb-FIX Cranial Stabilization Systems	Medical Bees GmbH	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2011	1	0
2012	1	0
2014	1	0
2025	1	0

FIG. 1 — Lineage of K021604, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HBL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HBL device

#1 K250423 mb-FIX Cranial Stabilization Systemsscore 13.0 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K923789	Mayfield Adult Disposable Skull Pin Summary page 1 …e Number: (513) 561-2241 ext. 2002 Contact Fax Number: (513) 332-2000 2. Name of predicate device(s): MAYFIELD Disposable Skull Pin 4-0-A-I 072 (K923789) 3. Classification: s882.4460 Neurosurgical Head Holder (skull clamp). (a) Identification:A neurosurgical head holder…	Ohio Medical Instrument Co., Inc.	1993	—

Also cleared against K923789: 2 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053045	Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020	Integra LifeSciences Corporation	2005	6
K071458	Mayfield Radiolucent Disposable Skull Pins	Integra LifeSciences Corporation	2007	5

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 29, 2004	Not classified	Z-1221-04	Other	Skull pins, which fractured below device specifications during QC testing, were distributed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K053045 (Integra LifeSciences Corporation, 2005) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K923789.

How does its category compare?

All HBL devices

HBL Holder, Head, Neurosurgical (Skull Clamp): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBL

1in 2025

2007high 3 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBL

54in 2009

2007high 54 (2009) · low 30 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HBL

1in 2025

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBL

272in 2025

2007high 1,028 (2019) · low 39 (2007)2025

MAUDE reports naming product code HBL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	30	0	39
2008	2	—	0	103
2009	3	54	0	97
2010	1	—	0	154
2011	1	—	0	199
2012	2	—	1	170
2013	2	—	1	148
2014	2	—	0	166
2015	0	—	0	196
2016	0	—	0	280
2017	1	—	1	296
2018	0	—	0	305
2019	2	—	1	1,028
2020	2	—	1	607
2021	1	—	0	512
2022	0	—	1	268
2023	0	—	0	265
2024	2	—	0	197
2025	1	—	1	272
2026	0	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021604 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021604: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021604

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026