510(k) · Cleared
ClearedVertos mild Device Kit (MDK-0002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertos Medical, Inc. · HRX Arthroscope
Cleared on May 6, 2024 as substantially equivalent to K093062 (X-Sten Corp., 2010) after a 159-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- May 6, 2024
- Review
- 159 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922881 (1992). 40 ancestors in all, the oldest K844131 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
- 5 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
- 4 generations backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
- 3 generations backK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
- 2 generations backK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- 1 generation backK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- This deviceK233800 Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK243774 ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations · 2025
- Descendant · cites it directly · 0 of its ownK253523 Freedom DS™ Decompression SystemSpinal Simplicity · 2026
- Descendant · 2 generations on · 0 of its ownK252546 VantageTM Lumbar Decompression KitAllevion Medical, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations · 2025 · cites it directly1descendant
- K253523Freedom DS™ Decompression SystemSpinal Simplicity · 2026 · cites it directly0descendants
- K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922881 | Clarus Models 1100, 1101, 1102, 1103 Laser Disc | Clarus Medical Systems, Inc. | 1992 | 1 |
| −5 | K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser… | Clarus Medical, LLC | 2002 | — |
| −4 | K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy… | Clarus Medical, LLC | 2004 | 1 |
| −3 | K040919 | Nucleotome Probe Set, Model 21200 | Clarus Medical, LLC | 2004 | 1 |
| −2 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| −1 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| 0 (this device) | K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024 | — |
| +1 | K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025 | — |
| +1 | K253523 | Freedom DS™ Decompression System | Spinal Simplicity | 2026 | — |
| +2 | K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K093062 | Vertos Medical Mild Device KitSummary page 5…ssification: Class II Product Code: HRX, HAE Classification Panel: Orthopedic III. Predicate Device Information (510(k) K093062) Device Trade Name: Vertos Medical mild Device Kit (MDK-0001) Device Common Name: Arthros… | 2010 |
What descends from it? (3)
2 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 32 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 40 ancestors have a recall of any class.
- Of its descendants, K243774 (Lesspine Innovations, 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K093062.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Vertos Medical mild Device Kit is a set of specialized surgical instruments intended to be used
to perform lumbar decompressive procedures for the treatment of various spinal conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233800: Vertos mild Device Kit (MDK-0002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233800
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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