510(k) · Cleared
ClearedDyonics Disposable Arthroscopic Surgery Blades Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Dyonics, Inc. · HRX Arthroscope
Cleared on Feb 14, 1994 after a 165-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 61 later devices descend from it.
- Decided
- Feb 14, 1994
- Review
- 165 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 3 citing it directly.
- This deviceK934299 Dyonics Disposable Arthroscopic Surgery Blades ModificationSmith & Nephew Dyonics, Inc. · 1994
- 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) | K934299 | Dyonics Disposable Arthroscopic Surgery Blades Modification | Smith & Nephew Dyonics, Inc. | 1994 | — |
| +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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, 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 HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
https://510kreport.com/device/K934299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K934299: Dyonics Disposable Arthroscopic Surgery Blades Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934299
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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