510(k) · Cleared
ClearedMayfield Radiolucent Disposable Skull Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Jun 13, 2007 as substantially equivalent to K021604 (Ohio Medical Instrument Co., Inc., 2002) and 1 other predicate after a 19-day review. Its family tree reaches back 3 generations to 1993. 5 later devices descend from it.
- Decided
- Jun 13, 2007
- Review
- 19 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923789 (1993). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK923789 Mayfield Adult Disposable Skull PinOhio Medical Instrument Co., Inc. · 1993
- 2 generations backK021604 Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Ohio Medical Instrument Co., Inc. · 2002 · Recalled
- 1 generation backK053045 Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Integra LifeSciences Corporation · 2005
- This deviceK071458 Mayfield Radiolucent Disposable Skull PinsIntegra LifeSciences Corporation · 2007
- Descendant · cites it directly · 4 of its ownK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- Descendant · 2 generations on · 2 of its ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025
- Descendant · 3 generations on · 0 of its ownK141950 HFD100 Rocker Arm AccessoryImris, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK113748 Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc. · 2012 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007 · cites it directly4descendants
- K103493Head Fiation Device (HFD 100)Imris, Inc. · 2011 · 2 generations on2descendants
- K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025 · 2 generations on0descendants
- K141950HFD100 Rocker Arm AccessoryImris, Inc. · 2014 · 3 generations on0descendants
- K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923789 | Mayfield Adult Disposable Skull Pin | Ohio Medical Instrument Co., Inc. | 1993 | — |
| −2 | K021604 | Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 | Ohio Medical Instrument Co., Inc. | 2002 | 1 |
| −1 | K053045 | Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 | Integra LifeSciences Corporation | 2005 | — |
| 0 (this device) | K071458 | Mayfield Radiolucent Disposable Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +1 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +2 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| +2 | K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025 | — |
| +3 | K141950 | HFD100 Rocker Arm Accessory | Imris, Inc. | 2014 | — |
| +3 | K113748 | Imris MR/X-Ray Head Fixation Device (HFD) | Imris, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K021604 | Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Summary page 1…lent in function and intended use to the unmodified Mayfield® Radiolucent Skull Pins which have been cleared to market under Premarket Notification 5 10(k) K02 1604 and K050345. Indications Use: The Mayfield®t Radiolucent Disposable Skull Pins are intended for use with a skull clamp… | 2002 |
| * | K053045 | Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 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”. | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | 2007 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K072208 (Integra LifeSciences Corporation, 2007) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K021604.
How does its category compare?
All HBL devicesHBL Holder, Head, Neurosurgical (Skull Clamp): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HBL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBL
54in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBL
272in 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071458: Mayfield Radiolucent Disposable Skull Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071458
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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