510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Surgical Cutting Burs

K943540510(k) TraditionalCleared Nov 30, 1994131-day reviewClass II21 CFR 872.4120Recalls 1

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

Stryker Corp. · DZJ Driver, Wire, And Bone Drill, Manual

Cleared on Nov 30, 1994 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 254 later devices descend from it. It has been recalled once.

Decided
Nov 30, 1994
Review
131 days
Class
Class II
Product code
DZJ
Recalls
1
Predicates
0

254 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 4 descendants cleared2003: 1 descendant cleared1999: 1 descendant cleared2010: 10 descendants cleared2007: 4 descendants cleared2013: 9 descendants cleared2002: 2 descendants cleared2008: 11 descendants cleared2016: 11 descendants cleared2006: 2 descendants cleared2025: 33 descendants cleared2017: 8 descendants cleared2021: 12 descendants cleared2022: 24 descendants cleared2024: 28 descendants cleared2015: 11 descendants cleared2011: 5 descendants cleared2023: 15 descendants cleared2009: 3 descendants cleared2014: 9 descendants cleared2018: 11 descendants cleared2020: 14 descendants cleared2012: 4 descendants cleared2019: 7 descendants cleared2026: 15 descendants cleared1990200020102020
  1. This deviceK943540 Surgical Cutting BursStryker Corp. · 1994
  2. Descendant · cites it directly · 253 of its ownK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
  3. Descendant · cites it directly · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
  4. Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
  5. Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
  6. Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

Showing 5 of 254 descendants. See all descendants

Descendants cleared per year

1999: 12002: 22003: 12004: 42006: 22007: 42008: 112009: 32010: 102011: 52012: 42013: 92014: 92015: 112016: 112017: 82018: 112019: 72020: 142021: 122022: 242023: 152024: 282025: 332026: 15
1999high 33 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 254 · See all
  • K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999 · cites it directly253descendants
  • K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · cites it directly238descendants
  • K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants
  • K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
  • K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943540Surgical Cutting BursStryker Corp.1994—
+1K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999—
+1K032117Stryker Total Performance (TPS) SystemStryker Instruments2003—
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004—
+3K060033Profile Multi-Platform SystemSciton, Inc2006—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200220
200310
200440
200620
200740
2008110
200930
2010100
201150
201240
201390
201490
2015110
2016110
201780
2018110
201970
2020140
2021120
2022240
2023150
2024280
2025330
2026150
FIG. 1 — Lineage of K943540, 1994–2026Source: 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.

Planning a device in DZJ? 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 DZJ device

  1. #1 K243637 Materialise Personalized Guides and Models for…score 13.7 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (254)

See all 254

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

NumberDeviceApplicantDecidedDescendants
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

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 2, 2013Class IIZ-0092-2014Nonconforming Material/ComponentIt was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K991696 (Stryker Instruments, 1999) has gone furthest, with 253 descendants of its own.

How does its category compare?

All DZJ devices

DZJ Driver, Wire, And Bone Drill, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZJ

1in 2025

2012: 12014: 12015: 22018: 22019: 12020: 42021: 32022: 32023: 32024: 12025: 12026 (partial year): 2
2007high 4 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZJ

142in 2023

2020: 379 days median2021: 403 days median2022: 179 days median2023: 142 days median
2007high 403 (2021) · low 142 (2023)2026

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

Recalls per year · DZJ

1in 2013

2011: 52013: 1
2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DZJ

14in 2025

2008: 102009: 1422010: 5172011: 5782012: 6212013: 8092014: 5392015: 182016: 162017: 92018: 82019: 42020: 172021: 222022: 232023: 222024: 132025: 14
2007high 809 (2013) · low 0 (2007)2025

MAUDE reports naming product code DZJ, 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—00
20080—010
20090—0142
20100—0517
20110—5578
20121—0621
20130—1809
20141—0539
20152—018
20160—016
20170—09
20182—08
20191—04
20204379017
20213403022
20223179023
20233142022
20241—013
20251—014
20262—0—

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https://510kreport.com/device/K943540 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943540: Surgical Cutting Burs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943540

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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