510(k) · Cleared
ClearedAnspach Helix Dissection Tools
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Jul 19, 2019 as substantially equivalent to K113476 (The Anspach Effort, Inc., 2011) after a 211-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jul 19, 2019
- Review
- 211 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011444 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011444 Anspach Emax Drill SystemThe Anspach Effort, Inc. · 2001 · Recalled
- 2 generations backK080802 Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware…The Anspach Effort, Inc. · 2008 · Recalled
- 1 generation backK113476 Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · Recalled
- This deviceK183545 Anspach Helix Dissection ToolsThe Anspach Effort, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011444 | Anspach Emax Drill System | The Anspach Effort, Inc. | 2001 | 70 |
| −2 | K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade… | The Anspach Effort, Inc. | 2008 | 35 |
| −1 | K113476 | Anspach Dissection Tools | The Anspach Effort, Inc. | 2011 | 39 |
| 0 (this device) | K183545 | Anspach Helix Dissection Tools | The Anspach Effort, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 HBE? 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 HBE device
- #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 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 |
|---|---|---|---|
| * | K113476 | Anspach Dissection ToolsSummary page 4…CFR 882.4310 Drills, burs, trephines, and accessories (simple, powered) Regulatory Class: II Product Code: HBE Classification panel: Neurology III. PREDICATE DEVICE K113476 Dissection Tools Owner: The Anspach Effort, Inc. Anspach Companies… | 2011 |
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 1 company; a new generation was cleared every 6.7 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 5 other devices also cite its predicate K113476.
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, 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 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183545: Anspach Helix Dissection Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183545
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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