510(k) · Cleared
ClearedMayfield Infinity Skull Clamp
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 Sep 20, 2005 after a 110-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Sep 20, 2005
- Review
- 110 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK051440 Mayfield Infinity Skull ClampIntegra Lifesciences Corp. · 2005
- Descendant · cites it directly · 5 of its ownK090506 Mayfield Infinity XR2 Skull Clamp, Model a-2114Integra LifeSciences Corporation · 2009
- Descendant · 2 generations on · 2 of its ownK120633 Mayfield Skull ClampIntegra LifeSciences Corporation · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK142238 MAYFIELD Skull ClampIntegra LifeSciences Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK130389 Mayfield Infinity XR2 Skull ClampIntegra LifeSciences Corporation · 2013
- Descendant · 4 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
Most influential descendants
Showing 5 of 7 · See all- K090506Mayfield Infinity XR2 Skull Clamp, Model a-2114Integra LifeSciences Corporation · 2009 · cites it directly5descendants
- K120633Mayfield Skull ClampIntegra LifeSciences Corporation · 2012 · 2 generations on2descendants
- K142238MAYFIELD Skull ClampIntegra LifeSciences Corporation · 2014 · 3 generations on1descendant
- K130389Mayfield Infinity XR2 Skull ClampIntegra LifeSciences Corporation · 2013 · 2 generations on1descendant
- K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051440 | Mayfield Infinity Skull Clamp | Integra Lifesciences Corp. | 2005 | — |
| +1 | K090506 | Mayfield Infinity XR2 Skull Clamp, Model a-2114 | Integra LifeSciences Corporation | 2009 | — |
| +2 | K120633 | Mayfield Skull Clamp | Integra LifeSciences Corporation | 2012 | 2 |
| +3 | K142238 | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | 2014 | — |
| +2 | K130389 | Mayfield Infinity XR2 Skull Clamp | Integra LifeSciences Corporation | 2013 | — |
| +4 | K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | — | Modified Mayfield® Skull Clamp Named without a submission number | |
| * | — | Mayfield A2000 Skull Clamp Named without a submission number | |
| * | — | DORO® Skull Clamp Named without a submission number |
What descends from it? (7)
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® Infinity 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 skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051440: Mayfield Infinity Skull Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051440
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