510(k) · Cleared
ClearedMidas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Powered Surgical Solutions · HBB Motor, Drill, Pneumatic
Cleared on Mar 26, 2009 as substantially equivalent to K020069 (Medtronic Midas Rex, 2002) after a 69-day review. Its family tree reaches back 1 generation to 2002. 20 later devices descend from it.
- Decided
- Mar 26, 2009
- Review
- 69 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020069 (2002). 20 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002 · Recalled
- This deviceK090112 Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710…Medtronic Powered Surgical Solutions · 2009
- Descendant · cites it directly · 10 of its ownK163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill…Medtronic Powered Surgical Solutions · 2017
- Descendant · cites it directly · 9 of its ownK160713 Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016
- Descendant · cites it directly · 7 of its ownK163565 MR8 Drill SystemMedtronic Powered Surgical Solutions · 2017
- Descendant · 2 generations on · 4 of its ownK220241 “POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Medtronic Powered Surgical Solutions · 2017 · cites it directly10descendants
- K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016 · cites it directly9descendants
- K163565MR8 Drill SystemMedtronic Powered Surgical Solutions · 2017 · cites it directly7descendants
- K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc. · 2022 · 2 generations on4descendants
- K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System… | Medtronic Midas Rex | 2002 | 9 |
| 0 (this device) | K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710… | Medtronic Powered Surgical Solutions | 2009 | — |
| +1 | K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System… | Medtronic Powered Surgical Solutions | 2017 | — |
| +1 | K160713 | Stealth-Midas System | Medtronic Powered Surgical Solutions | 2016 | — |
| +1 | K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | 2017 | — |
| +2 | K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc. | 2022 | — |
| +2 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 HBB? 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 HBB device
- #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…Summary page 1…e Midas Rex MR7 Pneumatic High Speed System is intended to be used with all existing Midas Rex Legend attachments and dissecting tools previously cleared through K020069. Indication for Use: The Medtronic Midas Rex MR7 System is a pneumatically operated surgical instrument system. The pneu… | 2002 |
What descends from it? (20)
See all 205 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?
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HBB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HBB
Too few HBB 510(k)s in any year since 2007 to give a median.
Recalls per year · HBB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBB
1,016in 2025
MAUDE reports naming product code HBB, 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 | 1 | — | 1 | 82 |
| 2008 | 0 | — | 1 | 176 |
| 2009 | 1 | — | 1 | 196 |
| 2010 | 2 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 399 |
| 2012 | 0 | — | 0 | 379 |
| 2013 | 0 | — | 1 | 685 |
| 2014 | 0 | — | 0 | 562 |
| 2015 | 1 | — | 1 | 440 |
| 2016 | 0 | — | 0 | 273 |
| 2017 | 1 | — | 1 | 203 |
| 2018 | 1 | — | 0 | 295 |
| 2019 | 0 | — | 0 | 284 |
| 2020 | 0 | — | 0 | 263 |
| 2021 | 0 | — | 0 | 260 |
| 2022 | 0 | — | 0 | 172 |
| 2023 | 0 | — | 0 | 180 |
| 2024 | 0 | — | 0 | 759 |
| 2025 | 0 | — | 2 | 1,016 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medtronic Midas Rex MR7 System is a pneumatically operated surgical instrument system. The pneumatic motors provide power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090112 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090112
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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