510(k) · Cleared
Recalled · Class II · 2021Stealth Autoguide System, Midas Rex Legend Depth Stop System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Nov 1, 2019 as substantially equivalent to K151359 (Medtech S.A, 2015) and 2 other predicates after a 137-day review. Its family tree reaches back 10 generations to 1986. 1 of the 92 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 1, 2019
- Review
- 137 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K862807 (1986). 87 ancestors in all, the oldest K811452 (1981). 4 later devices descend from it, 4 citing it directly. 1 of the 92 devices in this family, counting this one, has a Class I recall.
- 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 deviceK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
- Descendant · cites it directly · 1 of its ownK223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment…Brainlab AG · 2023
- Descendant · cites it directly · 0 of its ownK243698 Alignment System Cranial, with Alignment Software Cranial with LITT…Brainlab AG · 2025
- Descendant · cites it directly · 0 of its ownK213454 Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool…Medtronic Powered Surgical Solutions · 2021
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 deviceK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019
Class I recalls in this family
- K151359 ROSA Braindirect predicate · 2015
Most influential descendants
Showing 4 of 4 · See all- K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG · 2021 · cites it directly2descendants
- K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG · 2023 · cites it directly1descendant
- K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG · 2025 · cites it directly0descendants
- K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions · 2021 · cites it directly0descendants
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) | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | — |
| +1 | K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial… | Brainlab AG | 2021 | — |
| +1 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software… | Brainlab AG | 2023 | — |
| +1 | K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq… | Brainlab AG | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K151359 | ROSA BrainSummary page 6…urgical devices during such procedures. IX. Identification of Legally Marketed Devices (Predicate Devices): Stealth Autoguide™ System: Predicate: K151359 – ROSA Brain, manufactured by MEDTECH S.A Reference Devices: K131433 – iSYS1, manufactured by ISYS Referenc… | 2015 |
| * | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Summary page 6…nce Devices: K162604 – Cranial Reducing Tubes, manufactured by Medtronic Navigation, Inc. Midas Rex™ Legend™ Depth Stop System: Predicate: K170312, K163182 – Midas Rex Legend Electric and Pneumatic Drill Systems, manufactured by Medtronic Powered Surgical Systems.… | 2017 |
| * | K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Summary page 6…es: K162604 – Cranial Reducing Tubes, manufactured by Medtronic Navigation, Inc. Midas Rex™ Legend™ Depth Stop System: Predicate: K170312, K163182 – Midas Rex Legend Electric and Pneumatic Drill Systems, manufactured by Medtronic Powered Surgical Systems. === Page… | 2017 |
| † | K131433 | Isys 1 (U.S),Accessory, Non-Sterile | 2014 |
| † | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | 2017 |
| † | K162604 | Cranial Reducing Tubes | 2016 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic… | 2021 | 2 |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial… | 2023 | 1 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment… | 2025 | 0 |
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8… | 2021 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2021 | Class II | Z-0417-2022 | Process control | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it… |
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 · Direct predicate · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 13 of the 87 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210989 (Brainlab AG, 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K151359.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software. The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any…
Read the full statement (142 words)
The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic biopsy, stereotactic EEG, laser tissue ablation, etc.).
The Midas Rex™ Legend™ 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 as stated in the FDA summary.
https://510kreport.com/device/K191597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191597: Stealth Autoguide System, Midas Rex Legend Depth Stop System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191597
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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