510(k) Report

510(k) · Cleared

Cleared

Stryker S2 Drill

K141935510(k) SpecialCleared Sep 26, 201471-day reviewClass II21 CFR 874.4250

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

Stryker Corporation · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Cleared on Sep 26, 2014 as substantially equivalent to K112593 (Stryker Corporation, 2012) after a 71-day review. Its family tree reaches back 1 generation to 2012. 7 later devices descend from it.

Decided
Sep 26, 2014
Review
71 days
Class
Class II
Product code
ERL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K112593 (2012). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2021: 1 descendant cleared2024: 2 descendants cleared2025: 1 descendant cleared2026: 2 descendants clearedK112593 · Styker Consolidated Operating Room Equipment (Core) System · Stryker Corporation · 20122010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 3 descendants5 generations forward: 1 descendant K112593 · Styker Consolidated Operating Room Equipment (Core) System · Stryker Corporation · 20120+5
  1. Root · 1 generation backK112593 Styker Consolidated Operating Room Equipment (Core) SystemStryker Corporation · 2012
  2. This deviceK141935 Stryker S2 DrillStryker Corporation · 2014
  3. Descendant · cites it directly · 6 of its ownK152641 Pi Drive Plus Motor, ExtenderStryker Corporation · 2015
  4. Descendant · 2 generations on · 5 of its ownK211490 Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor…Stryker Corporation · 2021
  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 7 descendants. See all descendants

Descendants cleared per year

2015: 12021: 12024: 22025: 12026: 2
2015high 2 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · See all
  • K152641Pi Drive Plus Motor, ExtenderStryker Corporation · 2015 · cites it directly6descendants
  • K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number…Stryker Corporation · 2021 · 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
−1K112593Styker Consolidated Operating Room Equipment (Core) SystemStryker Corporation2012—
0 (this device)K141935Stryker S2 DrillStryker Corporation2014—
+1K152641Pi Drive Plus Motor, ExtenderStryker Corporation2015—
+2K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model…Stryker Corporation2021—
+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
201510
202110
202420
202510
202620
FIG. 1 — Lineage of K141935, 2012–2026Source: 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 ERL? 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 ERL device

  1. #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K112593Styker Consolidated Operating Room Equipment (Core) System
Summary page 4
…Consolidated Stryker K112593 ERL Operating Room…
Stryker Corporation2012—
*—Stryker CORE Sumex Drill
Named without a submission number
—

Also cleared against K112593: 5 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152641Pi Drive Plus Motor, ExtenderStryker Corporation20156

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 no recall.
  • Of its descendants, K152641 (Stryker Corporation, 2015) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K112593.

How does its category compare?

All ERL devices

ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · ERL

1in 2025

2008: 62009: 12012: 22013: 22014: 12015: 32016: 42017: 22018: 12019: 12020: 12021: 12022: 32024: 12025: 1
2007high 6 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ERL

191in 2022

2008: 181 days median2015: 86 days median2016: 180 days median2022: 191 days median
2007high 191 (2022) · low 86 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ERL

1in 2021

2009: 12013: 32020: 52021: 1
2007high 5 (2020) · low 0 (2007)2026

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

Adverse event reports per year · ERL

1,469in 2025

2007: 1122008: 602009: 2492010: 4442011: 1,0682012: 1,3792013: 3,2312014: 1,9752015: 2,6302016: 1,4552017: 9992018: 1,3802019: 2,5152020: 2,3692021: 2,2832022: 1,5742023: 1,7252024: 1,5882025: 1,469
2007high 3,231 (2013) · low 60 (2008)2025

MAUDE reports naming product code ERL, 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
20070—0112
20086181060
20091—1249
20100—0444
20110—01,068
20122—01,379
20132—33,231
20141—01,975
201538602,630
2016418001,455
20172—0999
20181—01,380
20191—02,515
20201—52,369
20211—12,283
2022319101,574
20230—01,725
20241—01,588
20251—01,469
20260—0—

What is it indicated for?

The Stryker S2 Drill is intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (ear, nose, and throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

Indications for use as stated in the FDA summary.

Also cleared against K112593

5 other devices cite the same predicate.

  • K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q…Stryker Leibinger GmbH & Co KG · 2024
  • K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Corporation · 2017
  • K143399Stryker Footed Attachments and Cutting AccessoriesStryker Corp. · 20151 recall
  • K143540Stryker MIS Attachments and Cutting AccessoriesStryker Corporation · 2015
  • K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. · 20157 recalls

More from Stryker Corporation

87 FDA decisions under this applicant name. See the company

  • K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice…Stryker Corporation · 2023
  • K223770Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023
  • K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker…Stryker Corporation · 20232 recalls
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating…Stryker Corporation · 2022
  • K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022

Recent decisions in ERL

The ERL category page

  • K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips)…W&H Dentalwerk Buermoos GmbH · 2025
  • K233958hekaDrillZethon, Ltd. · 2024
  • K221184ORiGO SystemBien-Air Surgery SA · 2022
  • K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022
  • K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022

https://510kreport.com/device/K141935 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141935: Stryker S2 Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141935

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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