510(k) · Cleared
ClearedStealth-Midas MR8 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Powered Surgical Solutions · OLO Orthopedic Stereotaxic Instrument
Cleared on May 22, 2019 as substantially equivalent to K160713 (Medtronic Powered Surgical Solutions, 2016) and 1 other predicate after a 147-day review. Its family tree reaches back 12 generations to 1986. 3 later devices descend from it.
- Decided
- May 22, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K862807 (1986). 74 ancestors in all, the oldest K842956 (1984). 3 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations between
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK160713 Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016
- This deviceK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
- Descendant · cites it directly · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK240568 DuraPro™ Oscillating SystemGlobus Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK202552 Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss) · 2020
Show all 12 generations
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 11 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 10 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 9 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 8 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 7 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 6 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 5 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 4 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK160713 Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016
- This deviceK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
Most influential descendants
Showing 3 of 3 · See all- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · cites it directly1descendant
- K240568DuraPro™ Oscillating SystemGlobus Medical, Inc. · 2024 · cites it directly0descendants
- K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss) · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −11 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −10 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −9 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −8 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −7 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −6 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −5 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −4 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −2 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K160713 | Stealth-Midas System | Medtronic Powered Surgical Solutions | 2016 | — |
| 0 (this device) | K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | 2019 | — |
| +1 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
| +1 | K240568 | DuraPro™ Oscillating System | Globus Medical, Inc. | 2024 | — |
| +1 | K202552 | Midas Rex Attachments and Dissecting Tools | Medtronic Powered Surgical Solutions (Mpss) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 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 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 2 | 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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K160713 | Stealth-Midas SystemSummary page 4…c images, or digitized landmarks of the anatomy. IX. Identification of Legally Marketed Devices (Predicate Devices): • Stealth-Midas System (K160713) Page 1 of 9. • MR8 D… | 2016 |
| * | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools Cleared while this submission was under review Summary page 5…ealth-Midas System (K160713) Page 1 of 9. • MR8 Drill System (K183515) X. Comparison of the Technological Characteristic: The only significant difference between the subject navigated handpie… | 2019 |
What descends from it? (3)
3 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 33 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 74 ancestors have a recall of any class.
- Of its descendants, K233638 (Globus Medical, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K160713.
How does its category compare?
All OLO devicesOLO Orthopedic 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 · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183644: Stealth-Midas MR8 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183644
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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