510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Endius Atavi System

K053267510(k) TraditionalCleared Jan 13, 200651-day reviewClass II21 CFR 888.1100Recalls 1

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

Endius, Inc. · HRX Arthroscope

Cleared on Jan 13, 2006 as substantially equivalent to K991794 (Endius, Inc., 1999) and 4 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1999. 42 later devices descend from it. It has been recalled once.

Decided
Jan 13, 2006
Review
51 days
Class
Class II
Product code
HRX
Recalls
1
Predicates
5

Its longest line of descent runs back 2 generations to K991794 (1999). 6 ancestors in all. 42 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 3 other ancestors2006: 3 descendants cleared2013: 3 descendants cleared2008: 1 descendant cleared2009: 3 descendants cleared2012: 8 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2018: 3 descendants cleared2021: 1 descendant cleared2024: 3 descendants cleared2015: 3 descendants cleared2019: 1 descendant cleared2025: 3 descendants cleared2026: 5 descendants cleared2017: 1 descendant clearedK991794 · Endoscopic Spinal Access System · Endius, Inc. · 1999K021748 · Endius Atavi System · Endius, Inc. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 10 descendants4 generations forward: 11 descendants5 generations forward: 8 descendants6 generations forward: 4 descendants K021748 · Endius Atavi System · Endius, Inc. · 2002K991794 · Endoscopic Spinal Access System · Endius, Inc. · 19990+5
  1. Root · 2 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
  2. 1 generation backK021748 Endius Atavi SystemEndius, Inc. · 2002
  3. This deviceK053267 Endius Atavi SystemEndius, Inc. · 2006
  4. Descendant · cites it directly · 25 of its ownK061246 Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
  5. Descendant · cites it directly · 17 of its ownK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006 · Recalled
  6. Descendant · 2 generations on · 16 of its ownK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
  7. Descendant · cites it directly · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
  8. Descendant · 2 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2006: 32008: 12009: 32010: 12011: 22012: 82013: 32014: 12015: 32017: 12018: 32019: 12021: 12024: 32025: 32026: 5
2006high 8 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 42 · See all
  • K061246Endoscopic Spine SystemArthro Kinetics, Inc. · 2006 · cites it directly25descendants
  • 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 · cites it directly14descendants
  • K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 2 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K991794Endoscopic Spinal Access SystemEndius, Inc.1999—
−1K021748Endius Atavi SystemEndius, Inc.2002—
0 (this device)K053267Endius Atavi SystemEndius, Inc.2006—
+1K061246Endoscopic Spine SystemArthro Kinetics, Inc.2006—
+1K061345Modification to Endius Atavi SystemEndius, Inc.20061
+2K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc.2008—
+1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.2006—
+2K093062Vertos Medical Mild Device KitX-Sten Corp.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200030
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200810
200930
201010
201120
201280
201330
201410
201530
201710
201830
201910
202110
202430
202530
202650
FIG. 1 — Lineage of K053267, 1999–2026Source: 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? (5)

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
*K991794Endoscopic Spinal Access System
Summary page 1
…to support position, or to work with the endoscope for the purpose of visualization. 5.5 Predicate Devices Device Name(s): Endius Atavi System 5 10(k) Nunmber(s): K991794, K994425, K002437, K021748, K022199…
Endius, Inc.1999—
*K994425Modification to Endoscopic Spinal Access System
Summary page 1
…rt position, or to work with the endoscope for the purpose of visualization. 5.5 Predicate Devices Device Name(s): Endius Atavi System 5 10(k) Nunmber(s): K991794, K994425, K002437, K021748, K022199 000912…
Endius, Inc.2000—
*K002437Endius Endoscopic Access System
Summary page 1
…ion, or to work with the endoscope for the purpose of visualization. 5.5 Predicate Devices Device Name(s): Endius Atavi System 5 10(k) Nunmber(s): K991794, K994425, K002437, K021748, K022199 000912 === Page…
Endius, Inc.2000—
*K021748Endius Atavi System
Summary page 1
…o work with the endoscope for the purpose of visualization. 5.5 Predicate Devices Device Name(s): Endius Atavi System 5 10(k) Nunmber(s): K991794, K994425, K002437, K021748, K022199 000912 En…
Endius, Inc.2002—
*K022199Endius Atavi System
Summary page 1
…th the endoscope for the purpose of visualization. 5.5 Predicate Devices Device Name(s): Endius Atavi System 5 10(k) Nunmber(s): K991794, K994425, K002437, K021748, K022199 000912 Endius, Inc…
Endius, Inc.2002—

Also cleared against K991794: 3 other devices →

What descends from it? (42)

See all 42

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

NumberDeviceApplicantDecidedDescendants
K061246Endoscopic Spine SystemArthro Kinetics, Inc.200625
K061345Modification to Endius Atavi SystemEndius, Inc.200617
K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 8, 2013Class IIZ-1045-2013Package design/selectionPossibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K061246 (Arthro Kinetics, Inc., 2006) has gone furthest, with 25 descendants of its own.
  • 3 other devices also cite its predicate K991794.

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 Endius Atavi System is indicated for use for posterior or anterior access and visualization in the surgical area of 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 Atavi system would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

Indications for use as stated in the FDA summary.

Also cleared against K991794

3 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
  • K021748Endius Atavi SystemEndius, Inc. · 2002

More from Endius, Inc.

33 FDA decisions under this applicant name. See the company

  • K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K073510Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2008
  • K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K072840Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
  • K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, 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/K053267 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053267: 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/K053267

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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