510(k) · Cleared
ClearedMidas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Powered Surgical Solutions · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Nov 23, 2021 as substantially equivalent to K191597 (Medtronic Navigation, Inc., 2019) after a 28-day review. Its family tree reaches back 11 generations to 1986. 1 of the 89 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 23, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K862807 (1986). 88 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet. 1 of the 89 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 7 generations between
- 3 generations backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- 2 generations backK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- 1 generation backK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- This deviceK213454 Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool…Medtronic Powered Surgical Solutions · 2021
Show all 11 generations
- Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 10 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 9 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 8 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 7 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 6 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 5 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 4 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 3 generations backK121264 Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies · 2012
- 2 generations backK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- 1 generation backK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- This deviceK213454 Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool…Medtronic Powered Surgical Solutions · 2021
Class I recalls in this family
- K151359 ROSA Brain2 generations back · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −10 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −9 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −8 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −7 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −6 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −5 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −4 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −3 | K121264 | Triton Electric High Torque Handpiece and Software Module | Medtronic Surgical Technologies | 2012 | — |
| −2 | 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 |
| 0 (this device) | K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm… | Medtronic Powered Surgical Solutions | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop SystemSummary page 4…burrs, trephines, and their accessories (21 CFR 882.4310) Classification: Class II Product Code: HBE Primary Predicate: Midas Rex Legend Depth Stop Attachment and Tools, K191597 Product Description: The Midas Rex MR8 Depth Stop attachment and tools are intended to create a cranial access hole of a known d… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151359ROSA BrainMedtech S.A · 2015 · 2 generations back · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 14 of the 88 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K191597.
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. 2021, 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 Midas Rex MR8 Depth Stop attachment and tools are indicated for the incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.
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/K213454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213454: Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213454
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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