510(k) Report

510(k) · Cleared

Cleared

Stryker Maestro System

K041754510(k) TraditionalCleared Sep 7, 200470-day reviewClass II21 CFR 882.4370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Corp. · HBB Motor, Drill, Pneumatic

Cleared on Sep 7, 2004 as substantially equivalent to K020069 (Medtronic Midas Rex, 2002) after a 70-day review. Its family tree reaches back 1 generation to 2002. 8 later devices descend from it.

Decided
Sep 7, 2004
Review
70 days
Class
Class II
Product code
HBB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K020069 (2002). 8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2019: 1 descendant cleared2026: 2 descendants cleared2024: 2 descendants cleared2025: 1 descendant clearedK020069 · Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System · Medtronic Midas Rex · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 3 descendants K020069 · Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System · Medtronic Midas Rex · 2002 · recalled0
  1. Root · 1 generation backK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002 · Recalled
  2. This deviceK041754 Stryker Maestro SystemStryker Corp. · 2004
  3. Descendant · cites it directly · 6 of its ownK143320 Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. · 2015 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK190172 Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker · 2019
  5. Descendant · 3 generations on · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
  6. Descendant · 4 generations on · 2 of its ownK241517 Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024
  7. Descendant · 4 generations on · 1 of its ownK252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q…Stryker Leibinger GmbH & Co KG · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 22019: 12024: 22025: 12026: 2
2015high 2 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all
  • K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. · 2015 · cites it directly6descendants
  • K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker · 2019 · 2 generations on5descendants
  • K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · 3 generations on4descendants
  • K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024 · 4 generations on2descendants
  • K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG · 2026 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020069Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System…Medtronic Midas Rex20029
0 (this device)K041754Stryker Maestro SystemStryker Corp.2004—
+1K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp.20157
+2K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker2019—
+3K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment…Stryker Leibinger GmbH & Co KG2024—
+4K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG2024—
+4K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments…Stryker Leibinger GmbH & Co KG2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201910
202420
202510
202620
FIG. 1 — Lineage of K041754, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K020069Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…
Summary page 1
…al drill, burrs, and accessories (HBE) Blades, saw, surgical cardiovascular (DWH) Equivalent to: Medltronic Legend®, Motor Drill Pneumatic (K020069), Device Description: The Stryker Maestro Pneumatic System is a pneumatic, high-speed instrument system…
Medtronic Midas Rex20029

Also cleared against K020069: 10 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp.20156
K150801Stryker Maestro Air MotorsStryker Corporation20151

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?

  • Its one ancestor has a recall.
  • Of its descendants, K143320 (Stryker Corp., 2015) has gone furthest, with 6 descendants of its own.
  • 10 other devices also cite its predicate K020069.

How does its category compare?

All HBB devices

HBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBB

1in 2018

2007: 12009: 12010: 22015: 12017: 12018: 12026 (partial year): 1
2007high 2 (2010) · low 0 (2008)2026

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

2007: 12008: 12009: 12013: 12015: 12017: 12025: 2
2007high 2 (2025) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBB

1,016in 2025

2007: 822008: 1762009: 1962010: 1832011: 3992012: 3792013: 6852014: 5622015: 4402016: 2732017: 2032018: 2952019: 2842020: 2632021: 2602022: 1722023: 1802024: 7592025: 1,016
2007high 1,016 (2025) · low 82 (2007)2025

MAUDE reports naming product code HBB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—182
20080—1176
20091—1196
20102—0183
20110—0399
20120—0379
20130—1685
20140—0562
20151—1440
20160—0273
20171—1203
20181—0295
20190—0284
20200—0263
20210—0260
20220—0172
20230—0180
20240—0759
20250—21,016
20261—0—

What is it indicated for?

The Stryker Maestro 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 as stated in the FDA summary.

Also cleared against K020069

10 other devices cite the same predicate.

  • K193630hekaDrillZethon, Ltd. · 2021
  • K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric…Medtronic Powered Surgical Solutions · 2017
  • K163565MR8 Drill SystemMedtronic Powered Surgical Solutions · 2017
  • K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic…Medtronic Powered Surgical Solutions · 2017
  • K093361Synthes Air Pen Drive (Apd) SystemSynthes (Usa) · 2010
  • K090112Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions · 2009

More from Stryker Corp.

156 FDA decisions under this applicant name. See the company

  • K230045HipCheckStryker Corp. · 2023
  • K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. · 2019
  • K182359HipCheckStryker Corp. · 2018
  • P050044/S033Vitagel RT3 Sutgical HemostatStryker Corp. · 2017
  • P050044/S032Vitagel RT3 Surgical HemostatStryker Corp. · 2015

Recent decisions in HBB

The HBB category page

  • K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AG · 2026
  • K172907ELAN 4 Air Motor SystemAesculap, Inc. · 20182 recalls
  • K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic…Medtronic Powered Surgical Solutions · 2017
  • K150801Stryker Maestro Air MotorsStryker Corporation · 20151 recall
  • K101168Legend Power Adapter Model: 6475000Medtronic Sofamor Danek · 2010

https://510kreport.com/device/K041754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041754: Stryker Maestro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041754

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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