510(k) · Cleared
Recalled · Class II · 2016Stryker Maestro Air Motors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · HBB Motor, Drill, Pneumatic
Cleared on May 22, 2015 as substantially equivalent to K041754 (Stryker Corp., 2004) after a 57-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- May 22, 2015
- Review
- 57 days
- Class
- Class II
- Product code
- HBB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020069 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002 · Recalled
- 1 generation backK041754 Stryker Maestro SystemStryker Corp. · 2004
- This deviceK150801 Stryker Maestro Air MotorsStryker Corporation · 2015
- Descendant · cites it directly · 0 of its ownK253623 Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine…Stryker Leibinger GmbH & Co KG · 2026
Most influential descendants
Showing 1 of 1 · See all- K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG · 2026 · cites it directly0descendants
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 | K041754 | Stryker Maestro System | Stryker Corp. | 2004 | — |
| 0 (this device) | K150801 | Stryker Maestro Air Motors | Stryker Corporation | 2015 | — |
| +1 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4… | Stryker Leibinger GmbH & Co KG | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K041754 | Stryker Maestro SystemSummary page 4…Product Code HBB, Class II 510(k) Predicate Device Stryker Maestro Pneumatic System, K041754 Indication for Use The Stryker® Consolidated Operating Room… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2016 | Class II | Z-1939-2016 | Component design/selection | Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. The grease may also migrate into the attachment end of the motor. There is a negligible possibility that the orange grease may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K253623 (Stryker Leibinger GmbH & Co KG, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K041754.
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Stryker® Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatic 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150801: Stryker Maestro Air Motors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150801
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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