510(k) · Cleared
ClearedFixit Headrest Clamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicon EG · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Mar 10, 2010 as substantially equivalent to K051440 (Integra Lifesciences Corp., 2005) and 5 other predicates after a 443-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 10, 2010
- Review
- 443 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K912011 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912011 Codman Skull ClampCodman & Shurtleff, Inc. · 1991
- This deviceK083803 Fixit Headrest Clamp SystemMedicon EG · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912011 | Codman Skull Clamp | Codman & Shurtleff, Inc. | 1991 | — |
| 0 (this device) | K083803 | Fixit Headrest Clamp System | Medicon EG | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 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? (6)
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 |
|---|---|---|---|
| * | K051440 | Mayfield Infinity Skull ClampSummary page 2…e and does not raise new issues of safety and effectiveness. o Schaerer Mayfield Infinity Skull Clamp, Integra Lifesciences Corp. (K051 440) o Doro Headrest System, PMI Freiburg, Germany (K001808) o PSI Skull Clamp, V. Mueller (K002275)… | 2005 |
| * | K001808 | Doro Headrest SystemSummary page 2…o Schaerer Mayfield Infinity Skull Clamp, Integra Lifesciences Corp. (K051 440) o Doro Headrest System, PMI Freiburg, Germany (K001808) o PSI Skull Clamp, V. Mueller (K002275) o Radiolucent Head Frame, Mizuho (K955012) o… | 2000 |
| * | K002276 | Psi Skull Clamp Our reading of the summary gave K002275, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PSI Skull Clamp”. | 2000 |
| * | K955012 | Mizuho Radiolucent Head FrameSummary page 2…o Doro Headrest System, PMI Freiburg, Germany (K001808) o PSI Skull Clamp, V. Mueller (K002275) o Radiolucent Head Frame, Mizuho (K955012) o Skull Clamp, Codman (K(91201 1) o Mayfield A-2000 Skull Clamp, OHIO Medical (K932807) For… | 1996 |
| * | K912011 | Codman Skull Clamp | 1991 |
| * | K932807 | Mayfield* a-2000 Skull ClampSummary page 2…5) o Radiolucent Head Frame, Mizuho (K955012) o Skull Clamp, Codman (K(91201 1) o Mayfield A-2000 Skull Clamp, OHIO Medical (K932807) For Predicate Device Catalogs please see Exhibit 4-9. 2.6 Device Description The Medicon Eixit Head Rest Syst… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K051440.
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. 2010, 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 Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083803: Fixit Headrest Clamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083803
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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