510(k) · Cleared
Recalled · 2010Headfix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Intelligence Medizintechnik GmbH · IYE Accelerator, Linear, Medical
Cleared on May 8, 2003 after an 86-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- May 8, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK030439 HeadfixMedical Intelligence Medizintechnik GmbH · 2003
- Descendant · cites it directly · 2 of its ownK092083 Extend Frame System, Model 1009633Elekta Instrument AB · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK112210 FraxionMedical Intelligence Medizintechnik GmbH · 2011
- Descendant · cites it directly · 1 of its ownK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
- Descendant · 2 generations on · 0 of its ownK132908 Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage…Medtec, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK103616 Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011
Most influential descendants
Showing 5 of 5 · See all- K092083Extend Frame System, Model 1009633Elekta Instrument AB · 2009 · cites it directly2descendants
- K112210FraxionMedical Intelligence Medizintechnik GmbH · 2011 · cites it directly1descendant
- K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008 · cites it directly1descendant
- K132908Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base…Medtec, Inc. · 2014 · 2 generations on0descendants
- K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030439 | Headfix | Medical Intelligence Medizintechnik GmbH | 2003 | — |
| +1 | K092083 | Extend Frame System, Model 1009633 | Elekta Instrument AB | 2009 | 1 |
| +1 | K112210 | Fraxion | Medical Intelligence Medizintechnik GmbH | 2011 | — |
| +1 | K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | Aktina Medical Physics Corp. | 2008 | — |
| +2 | K132908 | Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint… | Medtec, Inc. | 2014 | — |
| +2 | K103616 | Pinpoint Stereotactic Head and Neck Localizer | Aktina Medical Physics Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | — | Radionics Gill-Thomas-Cosman (GTC) Relocatable Head Holder Named without a submission number | |
| * | — | Orfit Industries’ Raycast Immobilization Systems Hardware and Thermoplastic Materials Named without a submission number | |
| * | — | BrainLAB’s Brain Mask System Named without a submission number |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2010 | Not classified | Z-0538-2011 | Other | The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092083 (Elekta Instrument AB, 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
This product is intended for use by radiologists and surgeons for:
Positioning and repositioning of the patient’s head;
Stereotactic diagnostic localization; and
Stereotactic radiotherapy of cranial targets
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030439: Headfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030439
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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