510(k) · Cleared
Recalled · Class II · 2016Anspach Minimal Access Spinal Attachment (Masa) System
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 17, 2004 after a 72-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled 31 times.
- Decided
- Dec 17, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 31
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK042783 Anspach Minimal Access Spinal Attachment (Masa) SystemThe Anspach Effort, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK113476 Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 4 of its ownK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- Descendant · 3 generations on · 3 of its ownK232684 Surgify HaloSurgify Medical OY · 2023
- Descendant · 2 generations on · 3 of its ownK173066 OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018
- Descendant · 4 generations on · 2 of its ownK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
2011high 3 (2019) · low 0 (2012)2026
Most influential descendants
Showing 5 of 14 · See all- K113476Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · cites it directly13descendants
- K130755Hicut Highspeed InstrumentAdeor Medical AG · 2014 · 2 generations on4descendants
- K232684Surgify HaloSurgify Medical OY · 2023 · 3 generations on3descendants
- K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018 · 2 generations on3descendants
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042783 | Anspach Minimal Access Spinal Attachment (Masa) System | The Anspach Effort, Inc. | 2004 | — |
| +1 | K113476 | Anspach Dissection Tools | The Anspach Effort, Inc. | 2011 | 39 |
| +2 | K130755 | Hicut Highspeed Instrument | Adeor Medical AG | 2014 | — |
| +3 | K232684 | Surgify Halo | Surgify Medical OY | 2023 | — |
| +2 | K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018 | — |
| +4 | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Anspach Angled Micro-nose Attachment Named without a submission number | |
| * | — | Medtronic (Midas Rex) "Micro-Telescoping System" Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113476 | Anspach Dissection Tools | 2011 | 13 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2016 | Class II | Z-2003-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2009-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2004-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2007-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2011-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2005-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-2006-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 26, 2012 | Class II | Z-0708-2014 | Labeling False and Misleading | During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA… |
| Mar 29, 2012 | Class II | Z-0715-2014 | Error in labeling | Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs. |
| Mar 29, 2012 | Class II | Z-0753-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0762-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0763-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0764-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0758-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0759-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0761-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0768-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0750-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0754-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0749-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0751-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0752-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0755-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0756-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0757-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0760-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0765-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0766-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0767-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Mar 29, 2012 | Class II | Z-0769-2014 | Labeling Change Control | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA… |
| Oct 13, 2010 | Not classified | Z-2903-2011 | Nonconforming Material/Component | On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
The 5 latest of 31 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113476 (The Anspach Effort, Inc., 2011) has gone furthest, with 13 descendants of its own.
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.
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?
The Anspach Minimal Access Spinal Attachment system is indicated for use as a nosepiece attachment with Anspach pneumatic and electric surgical drill systems for surgical cutting, shaping and removal of bones, including bones of the spine and cranium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042783 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042783: Anspach Minimal Access Spinal Attachment (Masa) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042783
Report an extraction error
Are you the manufacturer?
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