510(k) Report

510(k) · Cleared

Cleared

75K Staight Drill

K943541510(k) TraditionalCleared May 18, 1995300-day reviewClass II21 CFR 882.4310

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

Stryker Corp. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on May 18, 1995 after a 300-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 697 devices in its family, counting itself, has a Class I recall. 696 later devices descend from it.

Decided
May 18, 1995
Review
300 days
Class
Class II
Product code
HBE
Recalls
None
Predicates
0

696 later devices descend from it, 7 citing it directly. 1 of the 697 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 4 descendants cleared2003: 1 descendant cleared1999: 1 descendant cleared2007: 5 descendants cleared2001: 1 descendant cleared2008: 13 descendants cleared2002: 3 descendants cleared2017: 23 descendants cleared2010: 10 descendants cleared2013: 13 descendants cleared2016: 19 descendants cleared2006: 2 descendants cleared2025: 97 descendants cleared2015: 18 descendants cleared2012: 5 descendants cleared2011: 6 descendants cleared2024: 89 descendants cleared2014: 12 descendants cleared2021: 54 descendants cleared, 1 with a Class I recall12022: 70 descendants cleared2019: 33 descendants cleared2026: 71 descendants cleared2018: 28 descendants cleared2020: 37 descendants cleared2023: 78 descendants cleared2009: 3 descendants cleared1995200020052010201520202025
  1. This deviceK943541 75K Staight DrillStryker Corp. · 1995
  2. Descendant · cites it directly · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
  3. Descendant · 2 generations on · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
  4. Descendant · 2 generations on · 420 of its ownK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
  5. Descendant · 3 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
  6. Descendant · 4 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled

Showing 5 of 696 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12002: 32003: 12004: 42006: 22007: 52008: 132009: 32010: 102011: 62012: 52013: 132014: 122015: 182016: 192017: 232018: 282019: 332020: 372021: 542022: 702023: 782024: 892025: 972026: 71
1999high 97 (2025) · low 0 (2000)2026

Class I recalls in this family

  • K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 696 · See all
  • K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · cites it directly447descendants
  • K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · 2 generations on443descendants
  • K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc. · 2008 · 2 generations on420descendants
  • K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 3 generations on418descendants
  • K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 4 generations on404descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K94354175K Staight DrillStryker Corp.1995—
+1K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001—
+2K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc.20083
+2K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.20081
+3K111520Ipc Powerease SystemMedtronic Xomed, Inc.20112
+4K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20131

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200230
200310
200440
200620
200750
2008130
200930
2010100
201160
201250
2013130
2014120
2015180
2016190
2017230
2018280
2019330
2020370
2021541
2022700
2023780
2024890
2025970
2026710
FIG. 1 — Lineage of K943541, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 HBE device

  1. #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (696)

See all 696

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

NumberDeviceApplicantDecidedDescendants
K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001447
K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999253
K032117Stryker Total Performance (TPS) SystemStryker Instruments2003238
K032303Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments200414
K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20047
K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments20047
K070876Stryker Twist DrillsStryker Craniomaxillofacial20070

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K012457 (Sodemsystems, 2001) has gone furthest, with 447 descendants of its own.

How does its category compare?

All HBE devices

HBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBE

6in 2025

2007: 22008: 22011: 22012: 12013: 12014: 22015: 32016: 22017: 22018: 22019: 52021: 62022: 22023: 22025: 62026 (partial year): 1
2007high 6 (2021) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBE

30in 2025

2015: 155 days median2019: 133 days median2021: 193 days median2025: 30 days median
2007high 193 (2021) · low 30 (2025)2026

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

Recalls per year · HBE

1in 2024

2008: 472009: 72010: 232011: 12012: 262013: 42016: 72017: 32021: 12023: 32024: 12026 (partial year): 19
2007high 47 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HBE

1,924in 2025

2007: 142008: 142009: 2422010: 4922011: 1,0132012: 1,1462013: 1,5832014: 5592015: 4832016: 8482017: 8482018: 7872019: 8362020: 1,0252021: 1,0472022: 9002023: 9482024: 1,1532025: 1,924
2007high 1,924 (2025) · low 14 (2007)2025

MAUDE reports naming product code HBE, 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
20072—014
20082—4714
20090—7242
20100—23492
20112—11,013
20121—261,146
20131—41,583
20142—0559
201531550483
20162—7848
20172—3848
20182—0787
201951330836
20200—01,025
2021619311,047
20222—0900
20232—3948
20240—11,153
202563001,924
20261—19—

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Recent decisions in HBE

The HBE category page

  • K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo…Surgify Medical OY · 202611 recalls
  • K250815Hubly Drill (H100)Hubly, Inc. · 2025
  • K252060GREENPhasor Health, LLC · 2025
  • K252662UniBurNakanishi, Inc. · 2025
  • K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20253 recalls

https://510kreport.com/device/K943541 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943541: 75K Staight Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943541

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026