510(k) · Cleared
ClearedHenke Sass Wolf of America Arthroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Henke Sass Wolf of America, Inc. · HRX Arthroscope
Cleared on Mar 18, 2008 as substantially equivalent to K962075 (Henke Sass Wolf of America, Inc., 1997) and 1 other predicate after a 19-day review. Its family tree reaches back 3 generations to 1983. 21 later devices descend from it.
- Decided
- Mar 18, 2008
- Review
- 19 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K833587 (1983). 14 ancestors in all, the oldest K771218 (1978). 21 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 2 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 1 generation backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- This deviceK080560 Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK093677 Stryker ArthroscopeStryker Endoscopy · 2010
- Descendant · cites it directly · 6 of its ownK181819 SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018
- Descendant · 2 generations on · 4 of its ownK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK223406 SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K093677Stryker ArthroscopeStryker Endoscopy · 2010 · cites it directly11descendants
- K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018 · cites it directly6descendants
- K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · 2 generations on4descendants
- K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · 3 generations on3descendants
- K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −2 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −1 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| 0 (this device) | K080560 | Henke Sass Wolf of America Arthroscope | Henke Sass Wolf of America, Inc. | 2008 | — |
| +1 | K093677 | Stryker Arthroscope | Stryker Endoscopy | 2010 | — |
| +1 | K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | 2018 | — |
| +2 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +3 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +2 | K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962075 | HSW GMBH ArthroscopeSummary page 2…bstantial equivalence is claimed: The Henke Sass Wolf of America Laparoscopes are substantially equivalent to the Henke Sass Wolf of America Laparoscope - K962075 and the Smith & Nephew, Inc. Arthroscope - K97 1253 in design, materials, methods of construction and intended use.… | 1997 |
| * | K971253 | Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSummary page 2…olf of America Laparoscopes are substantially equivalent to the Henke Sass Wolf of America Laparoscope - K962075 and the Smith & Nephew, Inc. Arthroscope - K97 1253 in design, materials, methods of construction and intended use. See Section 11 12. The intended use of the… | 1997 |
What descends from it? (21)
See all 214 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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K093677 (Stryker Endoscopy, 2010) has gone furthest, with 11 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. 2008, this device’s year, is highlighted.
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?
The HSW Arthroscope and accessories is a tubular endoscopic device with accessory devices which attach to the Arthroscope and is intended to examine and / or perform surgery on the interior of a joint. Arthroscopic minimal invasive procedures are performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular joint, ankle, elbow and feet (plantar fascia release).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080560: Henke Sass Wolf of America Arthroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080560
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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