510(k) · Cleared
ClearedMidas Rex Attachments and Dissecting Tools
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Powered Surgical Solutions (Mpss) · OLO Orthopedic Stereotaxic Instrument
Cleared on Nov 2, 2020 as substantially equivalent to K183515 (Medtronic Powered Surgical Solutions, 2019) and 1 other predicate after a 60-day review. Its family tree reaches back 13 generations to 1986.
- Decided
- Nov 2, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K862807 (1986). 75 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet.
- Root · 13 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 9 generations between
- 3 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK160713 Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016
- 1 generation backK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
- This deviceK202552 Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss) · 2020
Show all 13 generations
- Root · 13 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 12 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 11 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 10 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 9 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 8 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 7 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 6 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 5 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 4 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 3 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK160713 Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016
- 1 generation backK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
- This deviceK202552 Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss) · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −12 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −11 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −10 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −9 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −8 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −7 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −6 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −5 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −4 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −3 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K160713 | Stealth-Midas System | Medtronic Powered Surgical Solutions | 2016 | — |
| −1 | K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K183515 | MR8 Drill System, Midas Rex MR8 ClearView ToolsSummary page 4…egally marketed predicate devices are identified below: Predicate 510(k) Clearance Primary Predicate K183515 MR8™ Drill System and Midas S.E. 12-May-2019 Rex™ MR8™ ClearView™ Tools Additional Predicate… | 2019 |
| * | K183644 | Stealth-Midas MR8 SystemSummary page 4…K183515 MR8™ Drill System and Midas S.E. 12-May-2019 Rex™ MR8™ ClearView™ Tools Additional Predicate: K183644 Stealth Midas MR8™ System S.E. 22-May-2019… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 75 ancestors have a recall of any class.
- 1 other device also cites its predicate K183515.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Midas Rexn attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and
removal of hard tissue and bone in open and minimally invasive spine procedures.
Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in
either open or percutaneous procedures. Their use is indicated for any medical condition for 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/K202552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202552: Midas Rex Attachments and 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/K202552
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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