510(k) · Cleared
ClearedModification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020
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 Nov 21, 2005 as substantially equivalent to K021604 (Ohio Medical Instrument Co., Inc., 2002) after a 24-day review. Its family tree reaches back 2 generations to 1993. 6 later devices descend from it.
- Decided
- Nov 21, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923789 (1993). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923789 Mayfield Adult Disposable Skull PinOhio Medical Instrument Co., Inc. · 1993
- 1 generation backK021604 Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Ohio Medical Instrument Co., Inc. · 2002 · Recalled
- This deviceK053045 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
- Descendant · 4 generations on · 0 of its ownK141950 HFD100 Rocker Arm AccessoryImris, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K141950HFD100 Rocker Arm AccessoryImris, Inc. · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923789 | Mayfield Adult Disposable Skull Pin | Ohio Medical Instrument Co., Inc. | 1993 | — |
| −1 | K021604 | Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 | Ohio Medical Instrument Co., Inc. | 2002 | 1 |
| 0 (this device) | 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 | — |
| +4 | K141950 | HFD100 Rocker Arm Accessory | Imris, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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? (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 | 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 Prernarket Notification 510(k) K02 1604. Indications Use: The Mayfieldo Radiolucent Skull Pins are intended for use with a skull clamp that is placed on… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071458 | Mayfield Radiolucent Disposable Skull Pins | 2007 | 5 |
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 12 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K071458 (Integra LifeSciences Corporation, 2007) has gone furthest, with 5 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.
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 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/K053045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053045: Modification to: 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 6, 2026. https://510kreport.com/device/K053045
Report an extraction error
Are you the manufacturer?
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