510(k) · Cleared
ClearedArthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power Cord, Wands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 15, 2008 as substantially equivalent to K071709 (Arthrocare Corp., 2007) after a 33-day review. Its family tree reaches back 6 generations to 2001. 12 later devices descend from it.
- Decided
- Oct 15, 2008
- Review
- 33 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011083 (2001). 7 ancestors in all. 12 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 5 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 4 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 3 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 2 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 1 generation backK071709 Arthrocare System 12000Arthrocare Corp. · 2007
- This deviceK082666 Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot…Arthrocare Corp. · 2008
- Descendant · cites it directly · 4 of its ownK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- Descendant · 2 generations on · 3 of its ownK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- Descendant · 3 generations on · 2 of its ownK183346 FLOW 90 WandArthroCare Corporation · 2019
- Descendant · 4 generations on · 1 of its ownK240964 FLOW 90? WandArthroCare Corporation · 2024
- Descendant · cites it directly · 1 of its ownK220563 Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000…ArthroCare Corporation · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015 · cites it directly4descendants
- K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016 · 2 generations on3descendants
- K183346FLOW 90 WandArthroCare Corporation · 2019 · 3 generations on2descendants
- K240964FLOW 90? WandArthroCare Corporation · 2024 · 4 generations on1descendant
- K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System…ArthroCare Corporation · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −5 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −4 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −3 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −2 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −1 | K071709 | Arthrocare System 12000 | Arthrocare Corp. | 2007 | — |
| 0 (this device) | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control… | Arthrocare Corp. | 2008 | — |
| +1 | K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015 | — |
| +2 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | 2016 | — |
| +3 | K183346 | FLOW 90 Wand | ArthroCare Corporation | 2019 | — |
| +4 | K240964 | FLOW 90? Wand | ArthroCare Corporation | 2024 | — |
| +1 | K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION… | ArthroCare Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071709 | Arthrocare System 12000Summary page 1…nd Accessories (Class II, 21 CFR 878.4400, Product Code GEI) Predicate Devices ArthroCare ® System 12000 K071709 ProductDscription The ArthroCare ® System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller th… | 2007 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143235 | RF20000a Controller, FLOW 50 Wand | 2015 | 4 |
| K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System… | 2022 | 1 |
| K140578 | Arthroscopic Energy System | 2014 | 1 |
| K090393 | Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model… | 2009 | 1 |
| K161581 | Arthrex Synergy RF System | 2016 | 0 |
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 1 company; a new generation was cleared every 12 months on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K143235 (ArthroCare Corporation, 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K071709.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
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.
https://510kreport.com/device/K082666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082666: Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power Cord, Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082666
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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