510(k) · Cleared
ClearedEndius Atavi System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endius, Inc. · HRX Arthroscope
Cleared on Oct 2, 2002 as substantially equivalent to K002931 (Medtronic Sofamor Danek, Inc., 2000) after an 89-day review. Its family tree reaches back 1 generation to 2000. 43 later devices descend from it.
- Decided
- Oct 2, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002931 (2000). 43 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
- This deviceK022199 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
- Descendant · 2 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- 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
- K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| 0 (this device) | K022199 | 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 | — |
| +2 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K002931 | Metrx System | 2000 |
| * | — | Sofamor Danek Microendoscopic Discectomy System Named without a submission number |
What descends from it? (43)
See all 432 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?
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@AtaviTMSystem is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius@AtaviTMSystem would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022199: Endius Atavi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022199
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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