510(k) · Cleared
Recalled · Class II · 2014SE5 Arthroscopy Sytem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HRX Arthroscope
Cleared on Nov 10, 1994 after a 237-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 256 later devices descend from it. It has been recalled once.
- Decided
- Nov 10, 1994
- Review
- 237 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 0
256 later devices descend from it, 2 citing it directly.
- This deviceK941333 SE5 Arthroscopy SytemStryker Endoscopy · 1994
- Descendant · cites it directly · 254 of its ownK974771 Stryker SE5 Arthroscopy System with Hermes Voice ControlStryker Endoscopy · 1998
- Descendant · 2 generations on · 253 of its ownK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- Descendant · 3 generations on · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 4 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Showing 5 of 256 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 256 · See all- K974771Stryker SE5 Arthroscopy System with Hermes Voice ControlStryker Endoscopy · 1998 · cites it directly254descendants
- K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999 · 2 generations on253descendants
- K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · 3 generations on238descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 4 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941333 | SE5 Arthroscopy Sytem | Stryker Endoscopy | 1994 | — |
| +1 | K974771 | Stryker SE5 Arthroscopy System with Hermes Voice Control | Stryker Endoscopy | 1998 | — |
| +2 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| +3 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| +3 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +4 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 11 | 0 |
| 2009 | 3 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 12 | 0 |
| 2022 | 24 | 0 |
| 2023 | 15 | 0 |
| 2024 | 28 | 0 |
| 2025 | 33 | 0 |
| 2026 | 15 | 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? (256)
See all 2562 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2014 | Class II | Z-1872-2014 | Nonconforming Material/Component | STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K974771 (Stryker Endoscopy, 1998) has gone furthest, with 254 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/K941333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941333: SE5 Arthroscopy Sytem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941333
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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