510(k) Report

510(k) · Cleared

Cleared

X-Sten Mild Tool Kit, Model MTK-0001

K062038510(k) TraditionalCleared Dec 19, 2006153-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 Dec 19, 2006 as substantially equivalent to K053267 (Endius, Inc., 2006) and 10 other predicates after a 153-day review. Its family tree reaches back 4 generations to 1992. 14 later devices descend from it.

Decided
Dec 19, 2006
Review
153 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
12

Its longest line of descent runs back 4 generations to K922881 (1992). 37 ancestors in all, the oldest K844131 (1984). 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 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 ancestor2010: 1 descendant cleared2018: 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 19 other ancestors4 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K040919 · 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 · recalled0+5
  1. Root · 4 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
  2. 3 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
  3. 2 generations backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
  4. 1 generation backK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
  5. This deviceK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
  6. Descendant · cites it directly · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
  7. Descendant · 2 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
  8. Descendant · 3 generations on · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
  9. Descendant · 2 generations on · 5 of its ownK212636 CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021
  10. Descendant · 3 generations on · 4 of its ownK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12018: 12019: 12021: 12024: 22025: 32026: 4
2010high 4 (2026) · low 0 (2011)2026

Most influential descendants

Showing 5 of 14 · See all
  • K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · cites it directly13descendants
  • K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 2 generations on7descendants
  • K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · 3 generations on6descendants
  • K212636CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021 · 2 generations on5descendants
  • K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201810
201910
202110
202420
202530
202640
FIG. 1 — Lineage of K062038, 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? (12)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K053267Endius Atavi System
Summary page 1
…me Drive, Suite D San Jose, CA 95131-1841 Telephone: 408-437-3101 Predicate Devices: K053267 Endius Atavi System K022578 Endius FlexTip Blade…
Endius, Inc.20061
*K022578Endius Flextip Blade
Summary page 1
…41 Telephone: 408-437-3101 Predicate Devices: K053267 Endius Atavi System K022578 Endius FlexTip Blade K99 1794 Endius Endoscopic Spinal Access System…
Endius, Inc.2002—
*K991794Endoscopic Spinal Access System
Summary page 1
…K053267 Endius Atavi System K022578 Endius FlexTip Blade K99 1794 Endius Endoscopic Spinal Access System K983 144 Endius Flexposure Refra…
Endius, Inc.1999—
*K983144Flexposure Retractor
Summary page 1
…578 Endius FlexTip Blade K99 1794 Endius Endoscopic Spinal Access System K983 144 Endius Flexposure Refractor K052241 Eliman International Disc-Fx Syste…
Endius, Inc.1999—
*K052241Disc-FX System
Summary page 1
…Endius Endoscopic Spinal Access System K983 144 Endius Flexposure Refractor K052241 Eliman International Disc-Fx System K043602 Medtronic MAST QUADRANT R…
Ellman International, Inc.2006—
*K043602Quadrant Retractor System
Summary page 1
…Endius Flexposure Refractor K052241 Eliman International Disc-Fx System K043602 Medtronic MAST QUADRANT Retractor K00293 1 Medtronic METRIC…
Medtronic Sofamor Danek2005—
*K002931Metrx System
Summary page 1
…Eliman International Disc-Fx System K043602 Medtronic MAST QUADRANT Retractor K00293 1 Medtronic METRIC K041 123 HydroCision AthroJet Resector XT…
Medtronic Sofamor Danek, Inc.2000—
Kept off the family treeK041123FDA’s K041123 is Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703
Our reading of the summary gave K041123, FDA’s number for Rinspiration System,Rinspiration System Short Tip, Models… (Kerberos Proximal Solutions, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “HydroCision AthroJet Resector XT”. Kept off the family tree.
Summary page 1
…K043602 Medtronic MAST QUADRANT Retractor K00293 1 Medtronic METRIC K041 123 HydroCision AthroJet Resector XT K040919 Clarus 21200 Nucleotome Probe…
Kerberos Proximal Solutions, Inc.2004—
*K040919Nucleotome Probe Set, Model 21200
Summary page 1
…K00293 1 Medtronic METRIC K041 123 HydroCision AthroJet Resector XT K040919 Clarus 21200 Nucleotome Probe Set K032473 Stryker Dekompressor Percut…
Clarus Medical, LLC20041
*K032473Dekompressor Percutaneous Discectomy Probe
Summary page 1
…HydroCision AthroJet Resector XT K040919 Clarus 21200 Nucleotome Probe Set K032473 Stryker Dekompressor Percutaneous Discectomy Probe…
Stryker Instruments20033
*K002008Surgical Dynamics Spinal Retractor
Summary page 1
…K032473 Stryker Dekompressor Percutaneous Discectomy Probe K002008 Surgical Dynamics Spinal Refractor K992898 Bright Medical Dilatation…
United States Surgical, A Division of Tyco Healthc2000—
*K992898The Bright Medical Dilation Retractor System
Summary page 1
…Discectomy Probe K002008 Surgical Dynamics Spinal Refractor K992898 Bright Medical Dilatation Refractor System Intended Use: The X-Sten MILD Tool Kit is a set of…
Bright Medical Instruments1999—

Also cleared against K053267: 2 other devices →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093062Vertos Medical Mild Device KitX-Sten Corp.201013

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 14 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
  • 5 of the 37 ancestors have a recall of any class.
  • Of its descendants, K093062 (X-Sten Corp., 2010) has gone furthest, with 13 descendants of its own.
  • 2 other devices also cite its predicate K053267.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Indications for use as stated in the FDA summary.

Also cleared against K053267

2 other devices cite the same predicate.

  • K061246Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
  • K061345Modification to Endius Atavi SystemEndius, Inc. · 20061 recall

More from X-Sten Corp.

2 FDA decisions under this applicant name. See the company

  • K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010

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/K062038 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062038: X-Sten Mild Tool Kit, Model MTK-0001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062038

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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