510(k) · Cleared
ClearedTriton Electric High Torque Handpiece and Software Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Surgical Technologies · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Aug 27, 2012 as substantially equivalent to K081475 (Medtronic Xomed, Inc., 2008) and 2 other predicates after a 123-day review. Its family tree reaches back 8 generations to 1986. 12 later devices descend from it.
- Decided
- Aug 27, 2012
- Review
- 123 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K862807 (1986). 59 ancestors in all, the oldest K842956 (1984). 12 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 7 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 5 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 4 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 3 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 2 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 1 generation backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- This deviceK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- Descendant · cites it directly · 11 of its ownK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- Descendant · 2 generations on · 4 of its ownK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK183515 MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019
- Descendant · 3 generations on · 3 of its ownK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
- Descendant · 3 generations on · 2 of its ownK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions · 2017 · cites it directly11descendants
- K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · 2 generations on4descendants
- K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019 · 2 generations on4descendants
- K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019 · 3 generations on3descendants
- K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −7 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −5 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −4 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −3 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −2 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −1 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| 0 (this device) | 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 | — |
| +2 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | 1 |
| +2 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | 2019 | — |
| +3 | K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | 2019 | — |
| +3 | K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial… | Brainlab AG | 2021 | — |
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 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Summary page 2…M'uat~r -510(k) Numrbeir' Claz c XPS 4000 System, Midas Rex Legend EHS System, Integrated Meditronic Xomed, Inc. K081475 10/17/2008 Power Console (IPO) XPS 4000 System, Midas Rex Legend EHS System, Integrated Medltronic Xomed… | 2008 |
| * | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Summary page 2…nc. K081475 10/17/2008 Power Console (IPO) XPS 4000 System, Midas Rex Legend EHS System, Integrated Medltronic Xomed, Inc. K081277 09/05/2008 Power Console ([PC) ___________________ PC® POWEREASETM Sysem Me… | 2008 |
| * | K111520 | Ipc Powerease SystemSummary page 2…wer Console ([PC) ___________________ PC® POWEREASETM Sysem Metrnic Xomed, Inc. Kil1520 1/621 51 0(k) K1 11520 Comparison to Predicate Device: The TRITON Electric High Torque Handpiece and Software Module are similar in device design, fu… | 2011 |
| † | K870157 | Oscillating Saw/ Reciprocating Saw/ Drill-Reamer | 1987 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | 2017 | 11 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 59 ancestors have a recall of any class.
- Of its descendants, K170312 (Medtronic Powered Surgical Solutions, 2017) has gone furthest, with 11 descendants of its own.
- 10 other devices also cite its predicate K081475.
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. 2012, 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?
The IPO System with the TRITON Electric High-Torque Handpiece is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121264: Triton Electric High Torque Handpiece and Software Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121264
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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