510(k) · Cleared
Recalled · Class II · 2022Anspach Emax Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · HBC Motor, Drill, Electric
Cleared on Aug 8, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it. It has been recalled 70 times.
- Decided
- Aug 8, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- HBC
- Recalls
- 70
- Predicates
- 0
36 later devices descend from it, 9 citing it directly.
- This deviceK011444 Anspach Emax Drill SystemThe Anspach Effort, Inc. · 2001
- Descendant · cites it directly · 14 of its ownK080802 Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware…The Anspach Effort, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 13 of its ownK113476 Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · Recalled
- Descendant · cites it directly · 8 of its ownK020688 Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK032529 Hydrocision Arthrojet System with Cautery, Turboburr and Curette…Hydrocision, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 5 of its ownK041233 Arthrojet XTHydrocision, Inc. · 2004
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
2002high 4 (2002) · low 0 (2005)2026
Most influential descendants
Showing 5 of 36 · See all- K080802Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…The Anspach Effort, Inc. · 2008 · cites it directly14descendants
- K113476Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · 2 generations on13descendants
- K020688Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002 · cites it directly8descendants
- K032529Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc. · 2003 · 2 generations on6descendants
- K041233Arthrojet XTHydrocision, Inc. · 2004 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011444 | Anspach Emax Drill System | The Anspach Effort, Inc. | 2001 | — |
| +1 | K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade… | The Anspach Effort, Inc. | 2008 | 35 |
| +2 | K113476 | Anspach Dissection Tools | The Anspach Effort, Inc. | 2011 | 39 |
| +1 | K020688 | Hydrocision Arthojet System with Cautery and Turboburr | Hydrocision, Inc. | 2002 | — |
| +2 | K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models… | Hydrocision, Inc. | 2003 | 2 |
| +3 | K041233 | Arthrojet XT | Hydrocision, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBC? 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 HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (36)
See all 369 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP… | 2008 | 14 |
| K020688 | Hydrocision Arthojet System with Cautery and Turboburr | 2002 | 8 |
| K030576 | Anspach Irrigation Pump and Irrigation Pump II | 2003 | 2 |
| K133604 | Anspach EG1 High Speed System, G1 Attachments | 2014 | 1 |
| K131053 | Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System | 2013 | 1 |
| K022907 | Anspach Powered Kerrison System (PKS) | 2002 | 1 |
| K080444 | Conmed Linvatec Osprey Drill System | 2008 | 0 |
| K022986 | The Bioplate Battery Powered Drill | 2002 | 0 |
| K022942 | Craniocut | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2022 | Class II | Z-0924-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0917-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0921-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0919-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0922-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0923-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0916-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0920-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0918-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Oct 6, 2016 | Class II | Z-2023-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1931-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1946-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1933-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1953-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1930-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1950-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1988-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2012-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2025-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2022-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2020-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1994-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1985-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1932-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2014-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1999-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2024-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1951-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1987-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1958-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1991-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2029-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1947-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2027-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1954-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2013-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2000-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2028-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1990-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1986-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2030-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2002-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Jan 8, 2014 | Class II | Z-1574-2014 | Labeling mix-ups | Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product. |
| May 6, 2013 | Class II | Z-0779-2014 | Unknown/Undetermined by firm | Product did not reach expected sterility assurance level |
| Nov 28, 2012 | Class II | Z-1904-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1912-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1895-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1908-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1909-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1913-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080802 (The Anspach Effort, Inc., 2008) has gone furthest, with 14 descendants of its own.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBC
2in 2024
2007high 2 (2013) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
2007high 9 (2011) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
2007high 10,670 (2013) · low 1 (2010)2025
MAUDE reports naming product code HBC, 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 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K011444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011444: Anspach Emax Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011444
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026