510(k) · Cleared
Recalled · Class II · 2016Anspach 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 Dec 16, 2011 as substantially equivalent to K080802 (The Anspach Effort, Inc., 2008) and 1 other predicate after a 24-day review. Its family tree reaches back 2 generations to 2001. 13 later devices descend from it. It has been recalled 39 times.
- Decided
- Dec 16, 2011
- Review
- 24 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 39
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011444 (2001). 3 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK011444 Anspach Emax Drill SystemThe Anspach Effort, Inc. · 2001 · Recalled
- 1 generation backK080802 Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware…The Anspach Effort, Inc. · 2008 · Recalled
- This deviceK113476 Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- Descendant · 2 generations on · 3 of its ownK232684 Surgify HaloSurgify Medical OY · 2023
- Descendant · cites it directly · 3 of its ownK173066 OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018
- Descendant · 3 generations on · 2 of its ownK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
- Descendant · 4 generations on · 1 of its ownK251433 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
2014high 3 (2019) · low 0 (2015)2026
Most influential descendants
Showing 5 of 13 · See all- K130755Hicut Highspeed InstrumentAdeor Medical AG · 2014 · cites it directly4descendants
- K232684Surgify HaloSurgify Medical OY · 2023 · 2 generations on3descendants
- K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018 · cites it directly3descendants
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 3 generations on2descendants
- K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011444 | Anspach Emax Drill System | The Anspach Effort, Inc. | 2001 | 70 |
| −1 | K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade… | The Anspach Effort, Inc. | 2008 | 35 |
| 0 (this device) | K113476 | Anspach Dissection Tools | The Anspach Effort, Inc. | 2011 | — |
| +1 | K130755 | Hicut Highspeed Instrument | Adeor Medical AG | 2014 | — |
| +2 | K232684 | Surgify Halo | Surgify Medical OY | 2023 | — |
| +1 | K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018 | — |
| +3 | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 5 |
| +4 | K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…Summary page 1…21 CFR §882.4310 HBE Predicate Devices eMax2 Plus System (Component to system) K0 808 02 Minimal Access Spinal Attachment (MASA) System (Component to system)… | 2008 |
| * | K042783 | Anspach Minimal Access Spinal Attachment (Masa) SystemSummary page 1…K0 808 02 Minimal Access Spinal Attachment (MASA) System (Component to system) K042783 Device Description The Anspach Dissection Tools are the actual cutting devices designed exclus… | 2004 |
What descends from it? (13)
See all 136 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 |
|---|---|---|---|---|
| Aug 26, 2016 | Class II | Z-2840-2016 | Device Design | The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. |
| Aug 26, 2016 | Class II | Z-2837-2016 | Device Design | Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed. |
| Aug 26, 2016 | Class II | Z-2839-2016 | Device Design | The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. |
| Aug 26, 2016 | Class II | Z-2838-2016 | Device Design | The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. |
| Apr 13, 2015 | Class II | Z-2283-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2307-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2285-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2308-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2294-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2309-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2310-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2282-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2288-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2313-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2284-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2302-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2297-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2292-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2301-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2280-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2306-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2290-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2293-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2299-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2289-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2295-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2304-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2281-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2296-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2305-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2312-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2311-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2298-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2286-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2303-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2287-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2300-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Apr 13, 2015 | Class II | Z-2291-2015 | Device Design | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft… |
| Mar 4, 2011 | Class II | Z-1377-2013 | Labeling mix-ups | Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr. |
The 5 latest of 39 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 6.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K130755 (Adeor Medical AG, 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K080802.
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. 2011, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2007high 6 (2021) · low 0 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
2007high 193 (2021) · low 30 (2025)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
2007high 47 (2008) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
2007high 1,924 (2025) · low 14 (2007)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?
Dissection tools are intended for cutting and shaping bone including spine and cranium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113476: Anspach 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/K113476
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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