510(k) · Cleared
ClearedMR8 Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Powered Surgical Solutions · HBC Motor, Drill, Electric
Cleared on Mar 28, 2017 as substantially equivalent to K081475 (Medtronic Xomed, Inc., 2008) and 2 other predicates after a 99-day review. Its family tree reaches back 7 generations to 1986. 7 later devices descend from it.
- Decided
- Mar 28, 2017
- Review
- 99 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K862807 (1986). 29 ancestors in all, the oldest K852143 (1985). 7 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 6 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 5 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 4 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 3 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 2 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 1 generation backK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
- This deviceK163565 MR8 Drill SystemMedtronic Powered Surgical Solutions · 2017
- Descendant · cites it directly · 4 of its ownK183515 MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019
- Descendant · 2 generations on · 3 of its ownK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
- Descendant · 3 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK240568 DuraPro™ Oscillating SystemGlobus Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233958 hekaDrillZethon, Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019 · cites it directly4descendants
- K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019 · 2 generations on3descendants
- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 3 generations on1descendant
- K240568DuraPro™ Oscillating SystemGlobus Medical, Inc. · 2024 · 3 generations on0descendants
- K233958hekaDrillZethon, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −6 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −5 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −4 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −3 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −2 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −1 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
| 0 (this device) | K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | 2017 | — |
| +1 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | 2019 | — |
| +2 | K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | 2019 | — |
| +3 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
| +3 | K240568 | DuraPro™ Oscillating System | Globus Medical, Inc. | 2024 | — |
| +1 | K233958 | hekaDrill | Zethon, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 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 HBC? 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 HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 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? (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 |
|---|---|---|---|
| * | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Summary page 4…omy, and General Surgical Procedures. IX. Identification of Legally Marketed Devices (Predicate Devices) • Midas Rex Legend EHS Electric Drill System (K081475) K163565 Page 2 of 2 •… | 2008 |
| * | K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700Summary page 5…== Page 5 === K163565 Page 2 of 2 • Midas Rex MR7 Pneumatic High Speed System (K090112) • Midas Rex Legend System (K020069) X. Comparison of the Technological Characteristics: The currently av… | 2009 |
| * | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…Summary page 5…K163565 Page 2 of 2 • Midas Rex MR7 Pneumatic High Speed System (K090112) • Midas Rex Legend System (K020069) X. Comparison of the Technological Characteristics: The currently available Midas Rex Drill System consists of pneum… | 2002 |
What descends from it? (7)
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 31 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K183515 (Medtronic Powered Surgical Solutions, 2019) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K081475.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, 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 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163565: MR8 Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163565
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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