510(k) · Cleared
ClearedMayfield Infinity XR2 Skull Clamp
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 Apr 23, 2013 as substantially equivalent to K090506 (Integra LifeSciences Corporation, 2009) after a 67-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Apr 23, 2013
- Review
- 67 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050319 (2005). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK050319 Mayfield MR/CT Skull Clamp, Model 4-0-a-1104Integra Lifesciences Corp. · 2005
- 1 generation backK090506 Mayfield Infinity XR2 Skull Clamp, Model a-2114Integra LifeSciences Corporation · 2009
- This deviceK130389 Mayfield Infinity XR2 Skull ClampIntegra LifeSciences Corporation · 2013
- Descendant · cites it directly · 0 of its ownK211658 OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder…Noras Mri Products GmbH · 2022
Most influential descendants
Showing 1 of 1 · See all- K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet…Noras Mri Products GmbH · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K130389 | Mayfield Infinity XR2 Skull Clamp | Integra LifeSciences Corporation | 2013 | — |
| +1 | K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with… | Noras Mri Products GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K090506 | Mayfield Infinity XR2 Skull Clamp, Model a-2114Summary page 1…Class 11 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed I I MAYFIELDw Infinity XR2 Skull Clamp (K090506) 807.92(a)(4) - Device description The MAYFIELD Infinity Skull Clamp is a cranial stabilization device, designed to provide ri… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet… | 2022 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211658 (Noras Mri Products GmbH, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090506.
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. 2013, 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@ Infinity XR2 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 skeletal fixation is necessary.
In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm x-ray, digital subtraction techniques, and MR imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130389: Mayfield Infinity XR2 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/K130389
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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