510(k) · Cleared
ClearedDyonics Disposable Arthroscopic Blades
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 Sep 15, 1995 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 107 later devices descend from it.
- Decided
- Sep 15, 1995
- Review
- 38 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
107 later devices descend from it, 11 citing it directly.
- This deviceK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- Descendant · cites it directly · 60 of its ownK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- Descendant · cites it directly · 37 of its ownK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 34 of its ownK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 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
Showing 5 of 107 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 107 · See all- K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997 · cites it directly60descendants
- K031787Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · cites it directly37descendants
- K041774Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004 · 2 generations on34descendants
- K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005 · 2 generations on32descendants
- K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| +1 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| +1 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| +2 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| +2 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| +3 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 7 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (107)
See all 10711 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | 1997 | 60 |
| K031787 | Smith & Nephew Iur Morcellation System | 2003 | 37 |
| K023777 | Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123, 133, 153, 163, 173… | 2002 | 1 |
| K012536 | Reprocessed Powered Arthroscopic Accessories | 2001 | 1 |
| K130912 | Omnicut Resection Blade | 2013 | 0 |
| K060172 | Rema Shaver Blades | 2006 | 0 |
| K052695 | Suretek Medical Reprocessed Arthroscopic Blades and Burs | 2006 | 0 |
| K022744 | Reprocessed Used Disposable Arthroscopic Blades and Burs | 2002 | 0 |
| K012694 | Reprocessed Used Disposable Arthroscopic Blades and Burs | 2002 | 0 |
| K012652 | Reprocessed Dyonics Arthroscopic Burs | 2001 | 0 |
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/K953695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953695: Dyonics Disposable Arthroscopic Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953695
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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