510(k) · Cleared
ClearedSurgical Power System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guizhou Zirui Technology Co., Ltd. · HBC Motor, Drill, Electric
Cleared on Sep 11, 2026 as substantially equivalent to K170312 (Medtronic Powered Surgical Solutions, 2017) and 1 other predicate after a 262-day review. Its family tree reaches back 10 generations to 1986.
- Decided
- Sep 11, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K862807 (1986). 68 ancestors in all, the oldest K791101 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 6 generations between
- 3 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 2 generations backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- 1 generation backK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- This deviceK254174 Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 9 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 8 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 7 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 6 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 5 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 4 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 3 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 2 generations backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- 1 generation backK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- This deviceK254174 Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −9 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −8 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −7 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −6 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −5 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −4 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −3 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −2 | K121264 | Triton Electric High Torque Handpiece and Software Module | Medtronic Surgical Technologies | 2012 | — |
| −1 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | Medtronic Powered Surgical Solutions | 2017 | — |
| 0 (this device) | K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2024 | 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 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 K233153 Traus SSG10 Surgical Systemscore 8.9 · 4 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 |
|---|---|---|---|
| * | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Summary page 6…Legally Market Predicate Device Primary Predicate Device Device Name: Medtronic Electric Drill Systems 510(k) Number K170312 Product Code: HBC, HBE, HRX, HWE, EQJ, ERL, KFK Device Class Class 2 Manufa… | 2017 |
| * | K231403 | evoDrill Cranial PerforatorSummary page 6…Powered Surgical Solutions Secondary Predicate Device Device Name: evonos evoDrill Cranial Perforator 510(k) Number K231403 Product Code: HBF Device Class Class 2 Manufacturer… | 2024 |
| † | K182527 | ELAN 4 Tools | 2019 |
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 40 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 68 ancestors have a recall of any class.
- 2 other devices also cite its predicate K170312.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HBC
2in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 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 | — |
What is it indicated for?
The Surgical Power System is an electrically operated surgical instrument system. The handpiece provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery.
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/K254174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254174: Surgical Power System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254174
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026