510(k) Report

510(k) · Cleared

Cleared

Endoscopic Spine System

K061246510(k) TraditionalCleared Aug 23, 2006112-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

Arthro Kinetics, Inc. · HRX Arthroscope

Cleared on Aug 23, 2006 as substantially equivalent to K053267 (Endius, Inc., 2006) and 3 other predicates after a 112-day review. Its family tree reaches back 3 generations to 1999. 25 later devices descend from it.

Decided
Aug 23, 2006
Review
112 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K991794 (1999). 10 ancestors in all, the oldest K941967 (1994). 25 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1994: 2 other ancestors2002: 1 other ancestor2000: 3 other ancestors2013: 3 descendants cleared2008: 1 descendant cleared2009: 3 descendants cleared2011: 2 descendants cleared2012: 7 descendants cleared2014: 1 descendant cleared2018: 2 descendants cleared2015: 3 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK991794 · Endoscopic Spinal Access System · Endius, Inc. · 1999K021748 · Endius Atavi System · Endius, Inc. · 2002K053267 · Endius Atavi System · Endius, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants K053267 · Endius Atavi System · Endius, Inc. · 2006 · recalledK021748 · Endius Atavi System · Endius, Inc. · 2002K991794 · Endoscopic Spinal Access System · Endius, Inc. · 19990+5
  1. Root · 3 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
  2. 2 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
  3. 1 generation backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
  4. This deviceK061246 Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
  5. Descendant · cites it directly · 16 of its ownK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
  6. Descendant · 2 generations on · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
  7. Descendant · 2 generations on · 7 of its ownK090278 Enspire Debrider SystemSpine View, Inc. · 2009
  8. Descendant · 3 generations on · 6 of its ownK110992 Enspire Debrider SystemSpine View, Inc. · 2011
  9. Descendant · cites it directly · 5 of its ownK083552 Maxmorespine Tom StickHoogland Spine Products, GmbH · 2009

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2008: 12009: 32011: 22012: 72013: 32014: 12015: 32017: 12018: 22024: 12026: 1
2008high 7 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 25 · See all
  • K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008 · cites it directly16descendants
  • K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · 2 generations on7descendants
  • K090278Enspire Debrider SystemSpine View, Inc. · 2009 · 2 generations on7descendants
  • K110992Enspire Debrider SystemSpine View, Inc. · 2011 · 3 generations on6descendants
  • K083552Maxmorespine Tom StickHoogland Spine Products, GmbH · 2009 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K991794Endoscopic Spinal Access SystemEndius, Inc.1999—
−2K021748Endius Atavi SystemEndius, Inc.2002—
−1K053267Endius Atavi SystemEndius, Inc.20061
0 (this device)K061246Endoscopic Spine SystemArthro Kinetics, Inc.2006—
+1K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.2008—
+2K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc.2011—
+2K090278Enspire Debrider SystemSpine View, Inc.2009—
+3K110992Enspire Debrider SystemSpine View, Inc.2011—
+1K083552Maxmorespine Tom StickHoogland Spine Products, GmbH2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
200030
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200930
201120
201270
201330
201410
201530
201710
201820
202410
202610
FIG. 1 — Lineage of K061246, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (4)

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
*K053267Endius Atavi System
Summary page 1
…ame: Spinal Access System Classification Name: Arthroscope and Accessories 3. PREDICATE DEVICES * Endius Atari System (K053267) * Henke-Sass Wolf Endoscope ( K94 1967) * Joimax Thessys Multiscope (1(051827) * Viking Sys…
Endius, Inc.20061
*K941967HSW Laparoscope and Accessories
Summary page 1
…sification Name: Arthroscope and Accessories 3. PREDICATE DEVICES * Endius Atari System (K053267) * Henke-Sass Wolf Endoscope ( K94 1967) * Joimax Thessys Multiscope (1(051827) * Viking Systems.CCD camera (K941919) 4. DEVICE DESCRIPTIO…
Henke-Sass, Wolf GmbH1994—
*K051827Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys…
Summary page 1
…es 3. PREDICATE DEVICES * Endius Atari System (K053267) * Henke-Sass Wolf Endoscope ( K94 1967) * Joimax Thessys Multiscope (1(051827) * Viking Systems.CCD camera (K941919) 4. DEVICE DESCRIPTION The Arthro Kinetics Endoscopic Spine Syst…
Joimax GmbH2005—
*K941919Oktas Endoscopy Video Camera System
Summary page 1
…s Atari System (K053267) * Henke-Sass Wolf Endoscope ( K94 1967) * Joimax Thessys Multiscope (1(051827) * Viking Systems.CCD camera (K941919) 4. DEVICE DESCRIPTION The Arthro Kinetics Endoscopic Spine System consists of an Endoscope, light source, l…
Oktas1994—

Also cleared against K053267: 2 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.200816
K083552Maxmorespine Tom StickHoogland Spine Products, GmbH20095
K090132Maxmorespine Spinal SystemHoogland Spine Products, GmbH20091
K121261Asap MuitiscopeAsap Endoscopic Products GmbH20130

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 7 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K081051 (Spine View, Inc., 2008) has gone furthest, with 16 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 Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.

Indications for use as stated in the FDA summary.

Also cleared against K053267

2 other devices cite the same predicate.

  • K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
  • K061345Modification to Endius Atavi SystemEndius, Inc. · 20061 recall

More from Arthro Kinetics, Inc.

2 FDA decisions under this applicant name. See the company

  • K070874Arthro Kinetics Vesalius MR Generator, Models 2004-2006; Accessories for MR GeneratorArthro Kinetics, Inc. · 2007

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/K061246 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061246: Endoscopic Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061246

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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