510(k) Report

510(k) · Cleared

Cleared

Intra-Articular Shaver

K771218510(k) TraditionalCleared Feb 1, 1978211-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

Dyonics, Inc. · KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Cleared on Feb 1, 1978 after a 211-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 306 later devices descend from it.

Decided
Feb 1, 1978
Review
211 days
Class
Class I
Product code
KIJ
Recalls
None
Predicates
0

306 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2004: 4 descendants cleared2001: 4 descendants cleared1997: 1 descendant cleared2003: 1 descendant cleared2010: 13 descendants cleared2007: 5 descendants cleared2013: 10 descendants cleared2005: 1 descendant cleared2008: 13 descendants cleared1998: 1 descendant cleared2006: 2 descendants cleared2011: 8 descendants cleared2025: 32 descendants cleared2017: 9 descendants cleared2018: 14 descendants cleared2020: 17 descendants cleared2021: 16 descendants cleared2022: 27 descendants cleared2024: 31 descendants cleared2015: 15 descendants cleared2012: 7 descendants cleared2014: 14 descendants cleared2023: 15 descendants cleared2009: 3 descendants cleared2016: 14 descendants cleared2019: 11 descendants cleared2026: 18 descendants cleared19801990200020102020
  1. This deviceK771218 Intra-Articular ShaverDyonics, Inc. · 1978
  2. Descendant · cites it directly · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
  3. Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
  4. Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
  5. Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
  6. Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008

Showing 5 of 306 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12001: 42003: 12004: 42005: 12006: 22007: 52008: 132009: 32010: 132011: 82012: 72013: 102014: 142015: 152016: 142017: 92018: 142019: 112020: 172021: 162022: 272023: 152024: 312025: 322026: 18
1997high 32 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 306 · See all
  • 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
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K771218Intra-Articular ShaverDyonics, Inc.1978—
+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—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200140
200310
200440
200510
200620
200750
2008130
200930
2010130
201180
201270
2013100
2014140
2015150
2016140
201790
2018140
2019110
2020170
2021160
2022270
2023150
2024310
2025320
2026180
FIG. 1 — Lineage of K771218, 1978–2026Source: 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 KIJ? 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? (306)

See all 306

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

NumberDeviceApplicantDecidedDescendants
K032117Stryker Total Performance (TPS) SystemStryker Instruments2003238
K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc.199760
K032303Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments200414
K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20047
K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments20047
K012652Reprocessed Dyonics Arthroscopic BursAlliance Medical Corp.20010
K012611Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc.20010

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, K032117 (Stryker Instruments, 2003) has gone furthest, with 238 descendants of its own.

How does its category compare?

All KIJ devices

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

FDA decisions per year · KIJ

1in 2016

2010: 12012: 12016: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KIJ

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

Recalls per year · KIJ

10in 2008

2008: 10
2007high 10 (2008) · low 0 (2007)2026

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

Adverse event reports per year · KIJ

4in 2025

2007: 102008: 42009: 2652010: 4242011: 1,0802012: 6152013: 2882014: 362015: 362016: 112017: 12018: 12019: 12020: 12022: 42023: 62024: 82025: 4
2007high 1,080 (2011) · low 0 (2021)2025

MAUDE reports naming product code KIJ, 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—010
20080—104
20090—0265
20101—0424
20110—01,080
20121—0615
20130—0288
20140—036
20150—036
20161—011
20170—01
20180—01
20190—01
20200—01
20210—00
20220—04
20230—06
20240—08
20250—04
20260—0—

More from Dyonics, Inc.

19 FDA decisions under this applicant name. See the company

  • K900070Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
  • K896416Dyonics Shoulder Portal SystemDyonics, Inc. · 1990
  • K893136Surgi-Pak for Arthroscopic AcromioplastyDyonics, Inc. · 1989
  • K890665Modified Cannula, Trocar and Obturator AccessoriesDyonics, Inc. · 1989
  • K894728Dyonics Disposable Arthroscopic Surgical KnifeDyonics, Inc. · 1989

Recent decisions in KIJ

The KIJ category page

  • K163308SmartoJeil Medical Corporation · 2016
  • K112599Insurgical Single Use Power EquipmentInsurgical, LLC · 2012
  • K101563SmartoJeil Medical Corporation · 2010
  • K972367Stryker System 4000 Heavy Duty Battery Powered EquipmentStryker Instruments · 199710 recalls
  • K970378Stryker 2115 Replacement Battery (2115)Implant Resource, Inc. · 1997

https://510kreport.com/device/K771218 · printed Nov 6, 2026

Cite this page

510(k) Report. “K771218: Intra-Articular Shaver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771218

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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