510(k) · Cleared
ClearedIPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Powered Surgical Solutions · HBC Motor, Drill, Electric
Cleared on May 15, 2017 as substantially equivalent to K081475 (Medtronic Xomed, Inc., 2008) and 4 other predicates after a 103-day review. Its family tree reaches back 9 generations to 1986. 11 later devices descend from it.
- Decided
- May 15, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K862807 (1986). 62 ancestors in all, the oldest K842956 (1984). 11 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations between
- 3 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 2 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 1 generation backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- This deviceK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- Descendant · cites it directly · 4 of its ownK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- Descendant · cites it directly · 4 of its ownK183515 MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019
- Descendant · 2 generations on · 3 of its ownK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
- Descendant · 2 generations on · 2 of its ownK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
- Descendant · 3 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
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 backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 2 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 1 generation backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- This deviceK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · cites it directly4descendants
- K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019 · cites it directly4descendants
- K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019 · 2 generations on3descendants
- K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG · 2021 · 2 generations on2descendants
- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 3 generations on1descendant
View 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 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −2 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −1 | K121264 | Triton Electric High Torque Handpiece and Software Module | Medtronic Surgical Technologies | 2012 | — |
| 0 (this device) | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | Medtronic Powered Surgical Solutions | 2017 | — |
| +1 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | 1 |
| +1 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | 2019 | — |
| +2 | K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | 2019 | — |
| +2 | K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial… | Brainlab AG | 2021 | — |
| +3 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 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 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Summary page 5…Electric Drill System [XPS 4000 System, Midas Medtronic Electric Drill System K081475 Rex Legend EHS System, IPC) - IPC (Integrated Power Console) -… | 2008 |
| * | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery)Summary page 5…- IPC (Integrated Power Console) K081475 - Legend EHS Handpieces - Legend EHS Handpieces K081475, K012457 - Legend Stylus Touch Handpiece - Legend Stylus Touch Handpiece K081475, K012457 - Microsa… | 2001 |
| * | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…Summary page 5…Blades - Microsaw Handpieces and Blades K081475 - Surgical Dissecting Tools - Surgical Dissecting Tools K020069 - Surgical Dissecting Tools (Curved Bur) - Surgical Dissecting Tools (Curved Bur) K072315 - Legend Attachmen… | 2002 |
| * | K072315 | Midas Rex Curved BurSummary page 5…s - Surgical Dissecting Tools K020069 - Surgical Dissecting Tools (Curved Bur) - Surgical Dissecting Tools (Curved Bur) K072315 - Legend Attachments - Legend Attachments K020069 - Electric Foot Pe… | 2007 |
| * | K121264 | Triton Electric High Torque Handpiece and Software ModuleSummary page 5…- System Accessories K081475 Triton Electric High Torque Handpiece Triton Electric High Torque Handpiece K121264 - Triton Electric High Torque Handpiece - Triton Electric High Torque Handpiece K121264 - Surgical Dissect… | 2012 |
| Kept off the family tree | K870157 | FDA’s K870157 is Oscillating Saw/ Reciprocating Saw/ Drill-Reamer Our reading of the summary gave K870157, FDA’s number for Oscillating Saw/ Reciprocating Saw/ Drill-Reamer (Micro-Aire Surgical Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Surgical Dissecting Tools”. Kept off the family tree. Summary page 5…iece - Triton Electric High Torque Handpiece K121264 - Surgical Dissecting Tools - Surgical Dissecting Tools K121264, K870157 - Attachments - Attachments K121264, K870157 - System… | 1987 |
What descends from it? (11)
See all 113 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)
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 31 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 8 of the 62 ancestors have a recall of any class.
- Of its descendants, K191597 (Medtronic Navigation, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K081475.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Electric Drill System is…
Read the full statement (131 words)
The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy
- Lumbar Stenosis Decompression
- Posterior Lumbar lnterbody Fusion (PLIF)
- Transforaminal Lumbar Interbody Fusion (TLIF)
- Anterior Lumbar lnterbody Fusion (ALIF)
- Direct Lateral lnterbody Fusion (DLIF)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170312
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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