510(k) · Cleared
ClearedMedtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
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 23, 2017 as substantially equivalent to K870157 (Micro-Aire Surgical Instruments, Inc., 1987) and 3 other predicates after a 129-day review. Its family tree reaches back 2 generations to 2002. 10 later devices descend from it.
- Decided
- Mar 23, 2017
- Review
- 129 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K020069 (2002). 4 ancestors in all, the oldest K870157 (1987). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002 · Recalled
- 1 generation backK072315 Midas Rex Curved BurMedtronic Powered Surgical Solutions · 2007
- This deviceK163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill…Medtronic Powered Surgical Solutions · 2017
- Descendant · cites it directly · 4 of its ownK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
- 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 · 2 generations on · 2 of its ownK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021
- Descendant · 3 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · cites it directly4descendants
- 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
- K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG · 2021 · 2 generations on2descendants
- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System… | Medtronic Midas Rex | 2002 | 9 |
| −1 | K072315 | Midas Rex Curved Bur | Medtronic Powered Surgical Solutions | 2007 | — |
| 0 (this device) | K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System… | Medtronic Powered Surgical Solutions | 2017 | — |
| +1 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019 | 1 |
| +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 | — |
| +2 | K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial… | Brainlab AG | 2021 | — |
| +3 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K870157 | Oscillating Saw/ Reciprocating Saw/ Drill-ReamerSummary page 5…SYSTEM DESCRIPTION 510(k) NUMBER Triton Pneumatic Drill System Oscillating and Reciprocating Saw Drill-Reamer K870157 - Pneumatic Handpiece - Pneumatic Handpiece K870157 - Pneumatic Foot… | 1987 |
| * | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…Summary page 5…- System Accessories K870157 Legend Pneumatic High Speed System Legend Pneumatic High Speed System K020069 - Pneumatic Handpiece - Pneumatic Handpiece K020069 - Pneumatic Foot… | 2002 |
| * | K072315 | Midas Rex Curved BurSummary page 5…- Pneumatic Control Unit K020069 - Surgical Dissecting Tools - Surgical Dissecting Tools K020069, K072315 - Attachments - Attachments K020069 - System Accesso… | 2007 |
| * | K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700Summary page 5…- System Accessories K020069 Midas Rex MR7 Pneumatic High Speed System Midas Rex MR7 Pneumatic High Speed System K090112 - Pneumatic Handpiece - Pneumatic Handpiece K090112 - Pneumatic Foot… | 2009 |
What descends from it? (10)
2 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 15 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K191597 (Medtronic Navigation, Inc., 2019) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides 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. Additionally, the Pneumatic Drill System…
Read the full statement (130 words)
The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides 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.
Additionally, the Pneumatic Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy
- Lumbar Stenosis Decompression
- Posterior Lumbar lnterbody Fusion (PLIF)
- Transforaminal Lumbar Interbody Fusion (TLIF)
- Anterior Lumbar lnterbody Fusion (ALIF)
- Direct Lateral lnterbody Fusion (DLIF)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163182
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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