510(k) Report

510(k) · Cleared

Cleared

Vertos Medical Mild Device Kit

K093062510(k) TraditionalCleared Feb 4, 2010127-day reviewClass II21 CFR 888.1100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

X-Sten Corp. · HRX Arthroscope

Cleared on Feb 4, 2010 as substantially equivalent to K062038 (X-Sten Corp., 2006) and 1 other predicate after a 127-day review. Its family tree reaches back 5 generations to 1992. 13 later devices descend from it.

Decided
Feb 4, 2010
Review
127 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K922881 (1992). 39 ancestors in all, the oldest K844131 (1984). 13 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2005: 1 other ancestor2003: 1 other ancestor2002: 4 other ancestors2000: 4 other ancestors1999: 4 other ancestors2004: 1 other ancestor2001: 3 other ancestors1995: 5 other ancestors1994: 1 other ancestor1993: 1 other ancestor1991: 2 other ancestors1990: 1 other ancestor1984: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor2018: 1 descendant cleared2012: 1 descendant cleared2021: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2025: 3 descendants cleared2026: 4 descendants clearedK922881 · Clarus Models 1100, 1101, 1102, 1103 Laser Disc · Clarus Medical Systems, Inc. · 1992 · recalledK022610 · Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 · Clarus Medical, LLC · 2002×2: 2 generations cleared close together, K040424 (2004), K040919 (2004) K062038 · X-Sten Mild Tool Kit, Model MTK-0001 · X-Sten Corp. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 10 other ancestors3 generations back: 19 other ancestors5 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K062038 · X-Sten Mild Tool Kit, Model MTK-0001 · X-Sten Corp. · 2006K040919 · Nucleotome Probe Set, Model 21200 · Clarus Medical, LLC · 2004 · recalledK040424 · Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120 · Clarus Medical, LLC · 2004 · recalledK022610 · Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 · Clarus Medical, LLC · 2002K922881 · Clarus Models 1100, 1101, 1102, 1103 Laser Disc · Clarus Medical Systems, Inc. · 1992 · recalled−50
  1. Root · 5 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
  2. 4 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
  3. 3 generations backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
  4. 2 generations backK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
  5. 1 generation backK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
  6. This deviceK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
  7. Descendant · cites it directly · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
  8. Descendant · 2 generations on · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
  9. Descendant · cites it directly · 5 of its ownK212636 CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021
  10. Descendant · 2 generations on · 4 of its ownK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
  11. Descendant · cites it directly · 3 of its ownK233800 Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc. · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012: 12018: 12019: 12021: 12024: 22025: 32026: 4
2012high 4 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 13 · See all
  • K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · cites it directly7descendants
  • K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · 2 generations on6descendants
  • K212636CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021 · cites it directly5descendants
  • K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024 · 2 generations on4descendants
  • K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc. · 2024 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K922881Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc.19921
−4K022610Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser…Clarus Medical, LLC2002—
−3K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy…Clarus Medical, LLC20041
−2K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC20041
−1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.2006—
0 (this device)K093062Vertos Medical Mild Device KitX-Sten Corp.2010—
+1K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.2018—
+2K190201CORUS Spinal SystemProvidence Medical Technology, Inc.2019—
+1K212636CORUS Spinal System-XProvidence Medical Technology, Inc.2021—
+2K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.2024—
+1K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199010
199120
199310
199410
199550
199710
199810
199940
200040
200130
200240
200310
200410
200510
200620
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201810
201910
202110
202420
202530
202640
FIG. 1 — Lineage of K093062, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K062038X-Sten Mild Tool Kit, Model MTK-0001
Summary page 1
…X-Sten (renamed as Vertos Medical, Inc.) Predicate Device Common Name: Arthroscopic Accessories Predicate Device Premnarket Notification -# K062038 Predicate Device Classification: 21 CFR 888.1 100 Predicate Device Classification & Class II, Produc…
X-Sten Corp.2006—
*K062711Ultra Low Profile Rongeur
Summary page 1
…icate Device Manufacturer: Baxano, Inc Predicate Device Common Name: Manual Rongeur Predicate Device Prernarket Notification # K0627 11 Predicate Device Classification: 21 CFR 882.4840 Predicate Device Classification & Class II, Produ…
Baxano, Inc.2007—

What descends from it? (13)

See all 13

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187
K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215
K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243
K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120

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 18 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
  • 5 of the 39 ancestors have a recall of any class.
  • Of its descendants, K180876 (Providence Medical Technology, Inc., 2018) has gone furthest, with 7 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

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.

More from X-Sten Corp.

2 FDA decisions under this applicant name. See the company

  • K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K093062 · printed Nov 5, 2026

Cite this page

510(k) Report. “K093062: Vertos Medical Mild Device Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093062

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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