510(k) Report

510(k) · Cleared

Cleared

Surgical Instruments and Accessories

K942956510(k) TraditionalCleared Sep 23, 199492-day reviewClass I21 CFR 878.4820

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

Stryker Corp. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Cleared on Sep 23, 1994 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 254 later devices descend from it.

Decided
Sep 23, 1994
Review
92 days
Class
Class I
Product code
HWE
Recalls
None
Predicates
0

254 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2002: 2 descendants cleared2004: 4 descendants cleared2003: 1 descendant cleared2008: 11 descendants cleared2016: 11 descendants cleared2010: 10 descendants cleared2007: 4 descendants cleared2006: 2 descendants cleared2013: 9 descendants cleared2015: 11 descendants cleared2022: 24 descendants cleared2011: 5 descendants cleared2017: 8 descendants cleared2025: 33 descendants cleared2021: 12 descendants cleared2024: 28 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 deviceK942956 Surgical Instruments and AccessoriesStryker Corp. · 1994
  2. Descendant · cites it directly · 253 of its ownK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
  3. Descendant · 2 generations on · 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 · 2 generations on238descendants
  • 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)K942956Surgical Instruments and AccessoriesStryker Corp.1994—
+1K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999—
+2K032117Stryker 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 K942956, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (254)

See all 254

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

NumberDeviceApplicantDecidedDescendants
K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999253

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?

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

How does its category compare?

All HWE devices

HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWE

1in 2015

2007: 12011: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWE

Too few HWE 510(k)s in any year since 2007 to give a median.

Recalls per year · HWE

1in 2017

2009: 42010: 22011: 22013: 12014: 32015: 52016: 22017: 1
2007high 5 (2015) · low 0 (2007)2026

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

Adverse event reports per year · HWE

2,848in 2025

2007: 1232008: 722009: 1802010: 2972011: 1382012: 2212013: 1,2432014: 3,7942015: 5,5672016: 4,9742017: 5,0742018: 3,5892019: 3,4522020: 3,2482021: 3,1402022: 3,3272023: 3,3972024: 3,6862025: 2,848
2007high 5,567 (2015) · low 72 (2008)2025

MAUDE reports naming product code HWE, 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—0123
20080—072
20090—4180
20100—2297
20111—2138
20120—0221
20130—11,243
20140—33,794
20151—55,567
20160—24,974
20170—15,074
20180—03,589
20190—03,452
20200—03,248
20210—03,140
20220—03,327
20230—03,397
20240—03,686
20250—02,848
20260—0—

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 HWE

The HWE category page

  • K143191IntelliSense DrillMcginley Innovations · 2015
  • K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011
  • K063688Surgical Irrigation System, Irrigation TubeThe Anspach Effort, Inc. · 2007
  • K050766Explant Osteonecrosis Intervention Implant Removal SystemZimmer Trabecular · 2005
  • K043310Synthes (Usa) Electric Pen Drive SystemSynthes (Usa) · 20052 Class I recalls

https://510kreport.com/device/K942956 · printed Nov 5, 2026

Cite this page

510(k) Report. “K942956: Surgical Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K942956

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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