510(k) · Cleared
ClearedMayfield MR/CT Skull Clamp, Model 4-0-a-1104
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Mar 31, 2005 after a 50-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Mar 31, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK050319 Mayfield MR/CT Skull Clamp, Model 4-0-a-1104Integra Lifesciences Corp. · 2005
- Descendant · cites it directly · 5 of its ownK090506 Mayfield Infinity XR2 Skull Clamp, Model a-2114Integra LifeSciences Corporation · 2009
- Descendant · cites it directly · 3 of its ownK081401 Mayfield MR/X-Ray Skull ClampIntegra Lifesciences Corp. · 2008
- Descendant · 2 generations on · 2 of its ownK120633 Mayfield Skull ClampIntegra LifeSciences Corporation · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK142238 MAYFIELD Skull ClampIntegra LifeSciences Corporation · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K090506Mayfield Infinity XR2 Skull Clamp, Model a-2114Integra LifeSciences Corporation · 2009 · cites it directly5descendants
- K081401Mayfield MR/X-Ray Skull ClampIntegra Lifesciences Corp. · 2008 · cites it directly3descendants
- K120633Mayfield Skull ClampIntegra LifeSciences Corporation · 2012 · 2 generations on2descendants
- K103493Head Fiation Device (HFD 100)Imris, Inc. · 2011 · 2 generations on2descendants
- K142238MAYFIELD Skull ClampIntegra LifeSciences Corporation · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050319 | Mayfield MR/CT Skull Clamp, Model 4-0-a-1104 | Integra Lifesciences Corp. | 2005 | — |
| +1 | K090506 | Mayfield Infinity XR2 Skull Clamp, Model a-2114 | Integra LifeSciences Corporation | 2009 | — |
| +1 | K081401 | Mayfield MR/X-Ray Skull Clamp | Integra Lifesciences Corp. | 2008 | — |
| +2 | K120633 | Mayfield Skull Clamp | Integra LifeSciences Corporation | 2012 | 2 |
| +2 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| +3 | K142238 | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | Mayfield® Radiolucent Skull Clamp Named without a submission number |
What descends from it? (10)
2 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, K090506 (Integra LifeSciences Corporation, 2009) has gone furthest, with 5 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 | — |
What is it indicated for?
The Mayfield MR/CT Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intracperative CT and MR imaging, C-Arm x-ray, and digital subtraction techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050319: Mayfield MR/CT Skull Clamp, Model 4-0-a-1104.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050319
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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