510(k) · Cleared
ClearedIntra-Articular Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyonics, Inc. · KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Cleared on May 7, 1982 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 61 later devices descend from it.
- Decided
- May 7, 1982
- Review
- 87 days
- Class
- Class I
- Product code
- KIJ
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 3 citing it directly.
- This deviceK820367 Intra-Articular Surgical SystemDyonics, Inc. · 1982
- Descendant · cites it directly · 60 of its ownK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- Descendant · 2 generations on · 32 of its ownK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- Descendant · 3 generations on · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- Descendant · 2 generations on · 21 of its ownK080560 Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997 · cites it directly60descendants
- K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005 · 2 generations on32descendants
- K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · 3 generations on30descendants
- K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · 3 generations on21descendants
- K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820367 | Intra-Articular Surgical System | Dyonics, Inc. | 1982 | — |
| +1 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| +2 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| +3 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| +3 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| +2 | K080560 | Henke Sass Wolf of America Arthroscope | Henke Sass Wolf of America, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
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
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? (61)
See all 613 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K971253 (Smith & Nephew, Inc., 1997) has gone furthest, with 60 descendants of its own.
How does its category compare?
All KIJ devicesKIJ 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIJ
4in 2025
MAUDE reports naming product code KIJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 10 |
| 2008 | 0 | — | 10 | 4 |
| 2009 | 0 | — | 0 | 265 |
| 2010 | 1 | — | 0 | 424 |
| 2011 | 0 | — | 0 | 1,080 |
| 2012 | 1 | — | 0 | 615 |
| 2013 | 0 | — | 0 | 288 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K820367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820367: Intra-Articular Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820367
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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