510(k) · Cleared
ClearedMayfield Adult Disposable Skull Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohio Medical Instrument Co., Inc. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Feb 12, 1993 after a 199-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 12, 1993
- Review
- 199 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK923789 Mayfield Adult Disposable Skull PinOhio Medical Instrument Co., Inc. · 1993
- Descendant · cites it directly · 7 of its ownK021604 Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Ohio Medical Instrument Co., Inc. · 2002 · Recalled
- Descendant · 2 generations on · 6 of its ownK053045 Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Integra LifeSciences Corporation · 2005
- Descendant · 2 generations on · 5 of its ownK071458 Mayfield Radiolucent Disposable Skull PinsIntegra LifeSciences Corporation · 2007
- Descendant · 3 generations on · 4 of its ownK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- Descendant · cites it directly · 2 of its ownK163322 TZ SKULL PIN AdultTz Medical, Inc. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K021604Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Ohio Medical Instrument Co., Inc. · 2002 · cites it directly7descendants
- K053045Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020Integra LifeSciences Corporation · 2005 · 2 generations on6descendants
- K071458Mayfield Radiolucent Disposable Skull PinsIntegra LifeSciences Corporation · 2007 · 2 generations on5descendants
- K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007 · 3 generations on4descendants
- K163322TZ SKULL PIN AdultTz Medical, Inc. · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K053045 | Modification to: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020 | Integra LifeSciences Corporation | 2005 | — |
| +2 | K071458 | Mayfield Radiolucent Disposable Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +3 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +1 | K163322 | TZ SKULL PIN Adult | Tz Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K021604 (Ohio Medical Instrument Co., Inc., 2002) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K923789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923789: Mayfield Adult Disposable Skull Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923789
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026