510(k) Report

510(k) · Cleared

Cleared

Arthrocare System 12000

K071709510(k) TraditionalCleared Aug 7, 200746-day reviewClass II21 CFR 878.4400

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

Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 7, 2007 as substantially equivalent to K032504 (Arthrocare Corp., 2003) after a 46-day review. Its family tree reaches back 5 generations to 2001. 15 later devices descend from it.

Decided
Aug 7, 2007
Review
46 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K011083 (2001). 6 ancestors in all. 15 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2009: 2 descendants cleared2008: 2 descendants cleared2014: 2 descendants cleared2016: 2 descendants cleared2022: 1 descendant cleared2015: 2 descendants cleared2025: 1 descendant cleared2019: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK011083 · Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand · Arthrocare Corp. · 2001K013463 · Arthrocare Arthro Wands, Enetec Evac Plasma Wand · Arthrocare Corp. · 2001K020557 · Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2002K030551 · Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2003 · recalledK032504 · Arthrocare System · Arthrocare Corp. · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 5 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K032504 · Arthrocare System · Arthrocare Corp. · 2003K030551 · Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2003 · recalledK020557 · Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2002K013463 · Arthrocare Arthro Wands, Enetec Evac Plasma Wand · Arthrocare Corp. · 2001K011083 · Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand · Arthrocare Corp. · 2001−50+5
  1. Root · 5 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 4 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
  3. 3 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
  4. 2 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
  5. 1 generation backK032504 Arthrocare SystemArthrocare Corp. · 2003
  6. This deviceK071709 Arthrocare System 12000Arthrocare Corp. · 2007
  7. Descendant · cites it directly · 12 of its ownK082666 Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot…Arthrocare Corp. · 2008
  8. Descendant · 2 generations on · 4 of its ownK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
  9. Descendant · 3 generations on · 3 of its ownK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
  10. Descendant · 4 generations on · 2 of its ownK183346 FLOW 90 WandArthroCare Corporation · 2019
  11. Descendant · 5 generations on · 1 of its ownK240964 FLOW 90? WandArthroCare Corporation · 2024

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2008: 22009: 22014: 22015: 22016: 22019: 12022: 12024: 12025: 12026: 1
2008high 2 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 15 · See all
  • K082666Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Arthrocare Corp. · 2008 · cites it directly12descendants
  • K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015 · 2 generations on4descendants
  • K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016 · 3 generations on3descendants
  • K183346FLOW 90 WandArthroCare Corporation · 2019 · 4 generations on2descendants
  • K240964FLOW 90? WandArthroCare Corporation · 2024 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…Arthrocare Corp.2001—
−4K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001—
−3K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.2002—
−2K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…Arthrocare Corp.20031
−1K032504Arthrocare SystemArthrocare Corp.2003—
0 (this device)K071709Arthrocare System 12000Arthrocare Corp.2007—
+1K082666Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.2008—
+2K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation2015—
+3K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation2016—
+4K183346FLOW 90 WandArthroCare Corporation2019—
+5K240964FLOW 90? WandArthroCare Corporation2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200920
201420
201520
201620
201910
202210
202410
202510
202610
FIG. 1 — Lineage of K071709, 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), 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K032504Arthrocare System
Summary page 1
…nd Accessories (Class II, 21 CFR 878.4400, Product Code GEI) Predicate Devices ArthroCare® System K032504 Product Description The ArthroCare ® System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller…
Arthrocare Corp.2003—

Also cleared against K032504: 3 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K082666Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Arthrocare Corp.200812
K090393Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model…Arthrocare Corp.20091
K080282Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00…Arthrocare Corp.20081

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 6 years and passes through 1 company; a new generation was cleared every 5 months on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K082666 (Arthrocare Corp., 2008) has gone furthest, with 12 descendants of its own.
  • 3 other devices also cite its predicate K032504.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Arthroscopic and Orthopedic Procedures — Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) Ablation and Debridement * ACL/PCL — Knee * Acromioplasty — Shoulder * Articular Cartilage — All Joints * Bursectomy — All Joints * Chondroplasty — All Joints * Fascia —…

Read the full statement (269 words)

The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures — Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)

Ablation and Debridement

* ACL/PCL — Knee

* Acromioplasty — Shoulder

* Articular Cartilage — All Joints

* Bursectomy — All Joints

* Chondroplasty — All Joints

* Fascia — All Joints

* Ligament — All Joints

* Notchplasty — Knee

* Scar Tissue — All Joints

* Soft Tissue — All Joints

* Subacromial Decompression — Shoulder

* Synovectomy — All Joints

* Tendon — All Joints

Excision and Resection

* Acetabular Labrum — Hip

* Articular Labrum — All Joints

* Capsule — All Joints

* Capsular Release — Knee

* Cartilage Flaps — Knee

* Cysts — All Joints

* Discoid Meniscus — Knee

* Frozen Shoulder Release — Shoulder

* Glenoidale Labrum — Shoulder

* Lateral Release — Knee

* Ligament — All Joints

* Loose Bodies — All Joints

* Meniscal Cystectomy — Knee

* Meniscectomy — Knee

* Plica Removal — All Joints

* Scar Tissue — All Joints

* Soft Tissue — All Joints

* Synovial Membrane — All Joints

* Tendon — All Joints

* Triangular Fibrocartilage (TFCC) — Wrist

* Villusectomy — Knee

Coagulation

* ACL/PCL — Knee

* Articular Cartilage — All Joints

* Carpal Ligaments — Wrist

* Glenohumeral Capsule — Shoulder

* Ligament — All Joints

* Medial Retinaculum — Knee

* Rotator Cuff — Shoulder

* Tendon — All Joints

* Wrist Tendons — Wrist

Indications for use as stated in the FDA summary.

Also cleared against K032504

3 other devices cite the same predicate.

  • K173741Reprocessed ArthoCare Ablation WandRenovo, Inc. · 2018
  • K041810Serfas Energy SystemStryker Endoscopy · 20043 recalls
  • K033584Arthrocare ArthrowandsArthrocare Corp. · 20031 recall

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 GEI

The GEI category page

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  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K071709 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071709: Arthrocare System 12000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071709

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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