510(k) · Cleared
Recalled · Class II · 2026Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgify Medical OY · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Mar 13, 2025 as substantially equivalent to K232684 (Surgify Medical OY, 2023) after a 30-day review. Its family tree reaches back 9 generations to 1986. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 13, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 9 generations to K862807 (1986). 38 ancestors in all, the oldest K852143 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations between
- 3 generations backK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
- 2 generations backK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- 1 generation backK232684 Surgify HaloSurgify Medical OY · 2023
- This deviceK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025
- Descendant · cites it directly · 1 of its ownK251433 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK253627 Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify…Surgify Medical OY · 2026 · Recalled
Show all 9 generations
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 7 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 5 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 4 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 3 generations backK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
- 2 generations backK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- 1 generation backK232684 Surgify HaloSurgify Medical OY · 2023
- This deviceK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −8 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −7 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −5 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −4 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −3 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
| −2 | K130755 | Hicut Highspeed Instrument | Adeor Medical AG | 2014 | — |
| −1 | K232684 | Surgify Halo | Surgify Medical OY | 2023 | — |
| 0 (this device) | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | — |
| +1 | K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 3 |
| +2 | K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo… | Surgify Medical OY | 2026 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 13.1 · 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 |
|---|---|---|---|
| * | K232684 | Surgify HaloSummary page 5…ce Class: Class II Classification Neurology Panel: II. Predicate Device Predicate Name and 510(k) Number: Surgify Halo, K232684. III. Device Description The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-gr… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2026 | Class II | Z-2572-2026 | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Apr 30, 2026 | Class II | Z-2564-2026 | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Apr 30, 2026 | Class II | Z-2570-2026 | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Apr 30, 2026 | Class II | Z-2568-2026 | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Apr 30, 2026 | Class II | Z-2566-2026 | Under Investigation by firm | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 38 ancestors have a recall of any class.
- Of its descendants, K251433 (Surgify Medical OY, 2025) has gone furthest, with 1 descendant 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. 2025, 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?
Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in
Neurosurgical, Spinal, ENT, and general surgical procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250380: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250380
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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