510(k) · Cleared
ClearedIncl Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · HRX Arthroscope
Cleared on Dec 18, 1995 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Dec 18, 1995
- Review
- 69 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK955471 Incl EndoscopeSofamor Danek USA,Inc. · 1995
- Descendant · cites it directly · 15 of its ownK983144 Flexposure RetractorEndius, Inc. · 1999
- Descendant · 2 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- Descendant · 3 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- Descendant · 4 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
- Descendant · 5 generations on · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K983144Flexposure RetractorEndius, Inc. · 1999 · cites it directly15descendants
- K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants
- K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 3 generations on13descendants
- K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 4 generations on7descendants
- K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955471 | Incl Endoscope | Sofamor Danek USA,Inc. | 1995 | — |
| +1 | K983144 | Flexposure Retractor | Endius, Inc. | 1999 | — |
| +2 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| +3 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| +4 | K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018 | — |
| +5 | K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (19)
See all 193 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?
- Of its descendants, K983144 (Endius, Inc., 1999) has gone furthest, with 15 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/K955471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955471: Incl Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955471
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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