510(k) Report

510(k) · Cleared

Cleared

Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand

K011083510(k) TraditionalCleared Jun 28, 200179-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

Arthrocare Corp. · HRX Arthroscope

Cleared on Jun 28, 2001 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 156 later devices descend from it.

Decided
Jun 28, 2001
Review
79 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
0

156 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 5 descendants cleared2001: 1 descendant cleared2010: 5 descendants cleared2003: 5 descendants cleared2018: 7 descendants cleared2006: 3 descendants cleared2002: 3 descendants cleared2005: 4 descendants cleared2012: 12 descendants cleared2007: 6 descendants cleared2017: 8 descendants cleared2016: 15 descendants cleared2008: 13 descendants cleared2025: 4 descendants cleared2014: 8 descendants cleared2015: 10 descendants cleared2022: 6 descendants cleared2013: 8 descendants cleared2009: 6 descendants cleared2011: 6 descendants cleared2023: 7 descendants cleared2026: 3 descendants cleared2024: 3 descendants cleared2019: 3 descendants cleared2021: 2 descendants cleared2020: 3 descendants cleared200020052010201520202025
  1. This deviceK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. Descendant · cites it directly · 134 of its ownK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
  3. Descendant · 2 generations on · 76 of its ownK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
  4. Descendant · 2 generations on · 55 of its ownK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
  5. Descendant · 3 generations on · 52 of its ownK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
  6. Descendant · 4 generations on · 51 of its ownK032504 Arthrocare SystemArthrocare Corp. · 2003

Showing 5 of 156 descendants. See all descendants

Descendants cleared per year

2001: 12002: 32003: 52004: 52005: 42006: 32007: 62008: 132009: 62010: 52011: 62012: 122013: 82014: 82015: 102016: 152017: 82018: 72019: 32020: 32021: 22022: 62023: 72024: 32025: 42026: 3
2001high 15 (2016) · low 1 (2001)2026

Most influential descendants

Showing 5 of 156 · See all
  • K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001 · cites it directly134descendants
  • K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC · 2002 · 2 generations on76descendants
  • K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp. · 2002 · 2 generations on55descendants
  • K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control…Arthrocare Corp. · 2003 · 3 generations on52descendants
  • K032504Arthrocare SystemArthrocare Corp. · 2003 · 4 generations on51descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…Arthrocare Corp.2001—
+1K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC2002—
+2K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.2002—
+3K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…Arthrocare Corp.20031
+4K032504Arthrocare SystemArthrocare Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200230
200350
200450
200540
200630
200760
2008130
200960
201050
201160
2012120
201380
201480
2015100
2016150
201780
201870
201930
202030
202120
202260
202370
202430
202540
202630
FIG. 1 — Lineage of K011083, 2001–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (156)

See all 156

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

NumberDeviceApplicantDecidedDescendants
K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001134
K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc.200319
K041810Serfas Energy SystemStryker Endoscopy200417
K053567Athrocare Topaz ArthrowandsArthrocare Corp.20062
K173741Reprocessed ArthoCare Ablation WandRenovo, Inc.20180
K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc.20100

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?

  • Of its descendants, K013463 (Arthrocare Corp., 2001) has gone furthest, with 134 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—

More from Arthrocare Corp.

112 FDA decisions under this applicant name. See the company

  • K153186Adjustable Fixation DeviceArthrocare Corp. · 2016
  • K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp. · 2013
  • K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp Tipped Obturator…Arthrocare Corp. · 2013
  • K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide…Arthrocare Corp. · 2011
  • K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011

Recent decisions in HRX

The HRX category page

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  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
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https://510kreport.com/device/K011083 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011083: Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011083

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026