510(k) · Cleared
ClearedStryker Arthroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HRX Arthroscope
Cleared on Mar 5, 2010 as substantially equivalent to K080560 (Henke Sass Wolf of America, Inc., 2008) after a 98-day review. Its family tree reaches back 4 generations to 1983. 11 later devices descend from it.
- Decided
- Mar 5, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K833587 (1983). 15 ancestors in all, the oldest K771218 (1978). 11 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 3 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 2 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 1 generation backK080560 Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008
- This deviceK093677 Stryker ArthroscopeStryker Endoscopy · 2010
- Descendant · cites it directly · 4 of its ownK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK140903 Nuvis ArthroscopeIntegrated Endoscopy, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK202659 Stryker ArthroscopeStryker · 2020
- Descendant · 3 generations on · 1 of its ownK132433 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · cites it directly4descendants
- K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · 2 generations on3descendants
- K140903Nuvis ArthroscopeIntegrated Endoscopy, Inc. · 2014 · cites it directly2descendants
- K202659Stryker ArthroscopeStryker · 2020 · cites it directly1descendant
- K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −3 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −2 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −1 | K080560 | Henke Sass Wolf of America Arthroscope | Henke Sass Wolf of America, Inc. | 2008 | — |
| 0 (this device) | K093677 | Stryker Arthroscope | Stryker Endoscopy | 2010 | — |
| +1 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +2 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +1 | K140903 | Nuvis Arthroscope | Integrated Endoscopy, Inc. | 2014 | — |
| +1 | K202659 | Stryker Arthroscope | Stryker | 2020 | — |
| +3 | K132433 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2014 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K080560 | Henke Sass Wolf of America ArthroscopeSummary page 3…n, and biocompatibility testing requirements. The patient contacting materials are identical to the materials used in the predicated device (Henike Sass Wolf Arthroscdpe K080560). The Stryker Arthroscopes met all specified design and performance requirements. Predicate Devices: The Stryker Arthroscopes ar… | 2008 |
What descends from it? (11)
See all 115 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 27 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K100577 (Acclarent, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K080560.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal
view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes
are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist
(carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia
release).
No known contraindications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093677 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093677: Stryker Arthroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093677
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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