510(k) · Cleared
ClearedModified Uses of the Arthroscopic Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyonics, Inc. · HRX Arthroscope
Cleared on Feb 16, 1990 as substantially equivalent to K833587 (Dyonics, Inc., 1983) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 1983. 61 later devices descend from it.
- Decided
- Feb 16, 1990
- Review
- 43 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K833587 (1983). 2 ancestors in all. 61 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- This deviceK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 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 |
|---|---|---|---|---|---|
| −1 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| 0 (this device) | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
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), the FDA summary (predicates and indications), 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K771218A | Arthroscopic Surgical System Number could not be read Summary page 8…roscopic Surgical System for use in the decompression of bulging discs in the lumbar region of the spine. The original system was reviewed by FDA under 510(K) submission K771218A with subsequent modifications reviewed under K8202367, K833587 and K880150. The name of the modified system is the Percutaneous A… | |
| Kept off the family tree | K8202367 | Unnamed device Number could not be read Summary page 8…of bulging discs in the lumbar region of the spine. The original system was reviewed by FDA under 510(K) submission K771218A with subsequent modifications reviewed under K8202367, K833587 and K880150. The name of the modified system is the Percutaneous Arthroscopic Micro Discectomy System. The modified sys… | |
| * | K833587 | Disposable Arthroscopy BladeSummary page 8…discs in the lumbar region of the spine. The original system was reviewed by FDA under 510(K) submission K771218A with subsequent modifications reviewed under K8202367, K833587 and K880150. The name of the modified system is the Percutaneous Arthroscopic Micro Discectomy System. The modified system consi… | 1983 |
| * | K880150 | Pacesetter (TM) 3500 Arthroscopic Surgical SystemSummary page 8…e lumbar region of the spine. The original system was reviewed by FDA under 510(K) submission K771218A with subsequent modifications reviewed under K8202367, K833587 and K880150. The name of the modified system is the Percutaneous Arthroscopic Micro Discectomy System. The modified system consists of a can… | 1988 |
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?
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 | — |
What is it indicated for?
All patients are eligible for this
procedure if they meet the following criteria:
A. Unremitting, persistent radiculopathy at L3-L4, L4-L5, or
L5-S1 locations.
B. Failure to respond to conservative therapy.
C. VNeurological impairment as reflected by sensory deficits,
reflex abnormalities and motor weakness.
D. Correlative electromyography in the absence of correlative
neurological deficits.
E. Positive tension signs.
F. Correlative imaging studies showing subannular herniated
nucleus pulposus consistent with clinical findings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K900070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900070: Modified Uses of the Arthroscopic 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/K900070
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026