510(k) Report

510(k) · Cleared

Cleared

Endius Flextip Blade

K022578510(k) SpecialCleared Aug 23, 200218-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

Endius, Inc. · HRX Arthroscope

Cleared on Aug 23, 2002 as substantially equivalent to K950054 (Paladin Medical, Inc., 1995) after an 18-day review. Its family tree reaches back 1 generation to 1995. 16 later devices descend from it.

Decided
Aug 23, 2002
Review
18 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K950054 (1995). 16 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant cleared2012: 1 descendant cleared2021: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2025: 3 descendants cleared2026: 4 descendants clearedK950054 · Endo-Bend (TM) Shaver · Paladin Medical, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K950054 · Endo-Bend (TM) Shaver · Paladin Medical, Inc. · 19950+5
  1. Root · 1 generation backK950054 Endo-Bend (TM) ShaverPaladin Medical, Inc. · 1995
  2. This deviceK022578 Endius Flextip BladeEndius, Inc. · 2002
  3. Descendant · cites it directly · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
  4. Descendant · 2 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
  5. Descendant · 3 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
  6. Descendant · 4 generations on · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
  7. Descendant · 3 generations on · 5 of its ownK212636 CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 12012: 12018: 12019: 12021: 12024: 22025: 32026: 4
2006high 4 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 16 · See all
  • 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
  • K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 3 generations on7descendants
  • K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · 4 generations on6descendants
  • K212636CORUS Spinal System-XProvidence Medical Technology, Inc. · 2021 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950054Endo-Bend (TM) ShaverPaladin Medical, Inc.1995—
0 (this device)K022578Endius Flextip BladeEndius, Inc.2002—
+1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.2006—
+2K093062Vertos Medical Mild Device KitX-Sten Corp.2010—
+3K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.2018—
+4K190201CORUS Spinal SystemProvidence Medical Technology, Inc.2019—
+3K212636CORUS Spinal System-XProvidence Medical Technology, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201010
201210
201810
201910
202110
202420
202530
202640
FIG. 1 — Lineage of K022578, 1995–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K950054Endo-Bend (TM) Shaver
Summary page 1
…Arthroscopic Accessory: Bendable Shaver Classification Name: Arthroscope (HRX) 7.5 Predicate Endius Endo-Bend Shaver System: K950054 Device 000073 E…
Paladin Medical, Inc.1995—

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614
K090303Xtend-ST Nucleus Removal System, Model 9004Corespine Technologies, LLC20090

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?

  • Its one ancestor has no recall.
  • Of its descendants, K062038 (X-Sten Corp., 2006) has gone furthest, with 14 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.

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@FlexTip@Blade is an articulating soft tissue resector designed to be used as an

accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible

drive system, to perform percutaneous lumbar discectomies.

Indications for use as stated in the FDA summary.

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/K022578 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022578: Endius Flextip Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022578

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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