510(k) · Cleared
ClearedArcus Head Fixation Frame
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Interventions, Inc. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Nov 15, 2019 as substantially equivalent to K091439 (Surgivision, Inc., 2009) after a 143-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Nov 15, 2019
- Review
- 143 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K012495 (2001). 4 ancestors in all, the oldest K874298 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK012495 OR Table and Headholder/Magnetom Harmony, Symphony, Sonata SystemsSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 2 generations backK071179 Noras or Head HolderSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK091439 Head Fixation Arc and Table BaseSurgivision, Inc. · 2009
- This deviceK191701 Arcus Head Fixation FrameMri Interventions, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012495 | OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems | Siemens Medical Solutions USA, Inc. | 2001 | 1 |
| −2 | K071179 | Noras or Head Holder | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K091439 | Head Fixation Arc and Table Base | Surgivision, Inc. | 2009 | — |
| 0 (this device) | K191701 | Arcus Head Fixation Frame | Mri Interventions, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 |
|---|---|---|---|
| * | K091439 | Head Fixation Arc and Table BaseSummary page 4…me Neurosurgical head holder (skull clamp) Classification 21 C.F.R. § 882.4460 Product Code HBL Predicate Device SurgiVision, Inc.’s Head Fixation Arc and Table Base (K091439) Intended Use / Indications for Use The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient’… | 2009 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2019, 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 Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient’s head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191701: Arcus Head Fixation Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191701
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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