510(k) · Cleared
ClearedEndoscopic Spinal Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endius, Inc. · HRX Arthroscope
Cleared on Aug 13, 1999 after a 79-day review. The FDA summary names its predicate without a number. 44 later devices descend from it.
- Decided
- Aug 13, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 4 citing it directly.
- This deviceK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- Descendant · cites it directly · 43 of its ownK021748 Endius Atavi SystemEndius, Inc. · 2002
- Descendant · cites it directly · 42 of its ownK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 25 of its ownK061246 Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
- Descendant · cites it directly · 17 of its ownK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 16 of its ownK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K021748Endius Atavi SystemEndius, Inc. · 2002 · cites it directly43descendants
- K053267Endius Atavi SystemEndius, Inc. · 2006 · cites it directly42descendants
- K061246Endoscopic Spine SystemArthro Kinetics, Inc. · 2006 · 2 generations on25descendants
- K061345Modification to Endius Atavi SystemEndius, Inc. · 2006 · cites it directly17descendants
- K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991794 | Endoscopic Spinal Access System | Endius, Inc. | 1999 | — |
| +1 | K021748 | Endius Atavi System | Endius, Inc. | 2002 | — |
| +1 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| +2 | K061246 | Endoscopic Spine System | Arthro Kinetics, Inc. | 2006 | — |
| +1 | K061345 | Modification to Endius Atavi System | Endius, Inc. | 2006 | 1 |
| +2 | K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope | Spine View, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 8 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | — | Sofamor Danek USA Microendoscopic System Named without a submission number |
What descends from it? (44)
See all 444 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, K021748 (Endius, Inc., 2002) has gone furthest, with 43 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 | — |
What is it indicated for?
The Endius Endoscopic Access System is intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy and nucleotomy.
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/K991794 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991794: Endoscopic Spinal Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991794
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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