510(k) · Cleared
ClearedArthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model 72202139,72202141, 72202143, 72202144
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 Jun 23, 2009 as substantially equivalent to K071709 (Arthrocare Corp., 2007) and 3 other predicates after a 126-day review. Its family tree reaches back 12 generations to 2001. 1 later device descends from it.
- Decided
- Jun 23, 2009
- Review
- 126 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K011083 (2001). 26 ancestors in all, the oldest K000778 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 8 generations between
- 3 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 2 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 1 generation backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK090393 Arthrocare System 15000 Contoller, Model 72202149, Arthrocare…Arthrocare Corp. · 2009
- Descendant · cites it directly · 0 of its ownK093165 Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp. · 2009
Show all 12 generations
- Root · 12 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 11 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 10 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 9 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 8 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 7 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 6 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 5 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 4 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 3 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 2 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 1 generation backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK090393 Arthrocare System 15000 Contoller, Model 72202149, Arthrocare…Arthrocare Corp. · 2009
Most influential descendants
Showing 1 of 1 · See all- K093165Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −11 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −10 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −9 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −8 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −7 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −6 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −5 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −4 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −3 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −2 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −1 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| 0 (this device) | K090393 | Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands… | Arthrocare Corp. | 2009 | — |
| +1 | K093165 | Arthrocare System 15000 Controller, Arthrowands | Arthrocare Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (4)
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 1I, 21 CFR 878.4400, Product Code GEI) Predicate Devices ArthroCare System 12000 K07 1709 and K082666 ArthroCare ArthroWands K070958 and K082980 Product Description The ArthroCare System 15000 con… | 2007 |
| * | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Summary page 1…s (Class 1I, 21 CFR 878.4400, Product Code GEI) Predicate Devices ArthroCare System 12000 K07 1709 and K082666 ArthroCare ArthroWands K070958 and K082980 Product Description The ArthroCare System 15000 consists of a b… | 2008 |
| * | K070958 | Modification to Arthrocare ArthrowandsSummary page 1…878.4400, Product Code GEI) Predicate Devices ArthroCare System 12000 K07 1709 and K082666 ArthroCare ArthroWands K070958 and K082980 Product Description The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator cal… | 2007 |
| * | K082980 | Arthrocare ArthrowandsSummary page 1…878.4400, Product Code GEI) Predicate Devices ArthroCare System 12000 K07 1709 and K082666 ArthroCare ArthroWands K070958 and K082980 Product Description The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Cont… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093165 | Arthrocare System 15000 Controller, Arthrowands | 2009 | 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 8 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K093165 (Arthrocare Corp., 2009) has gone furthest, with 0 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. 2009, 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 15000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: 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…
Read the full statement (210 words)
The ArthroCare System 15000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
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
Meniscectomry — Knee
Plica Removal — All Joints
Scar Tissue — All Joints
Soft Tissue — All Joints
Synovial Membrane — All Joints
Tendon — All Joints
Triangular Fibrocartilage (TFCC) — Wrist
Villusectomny — Knee
Coagulation
ACL/PCL — Knee
Articular Cartilage — All Joints
Carpal Ligaments — Wrist
Glenohumneral Capsule — Shoulder
Ligam ent — All Joints
Medial Retinaculumn — Knee
Rotator Cuff — Shoulder
Tendon — All Joints
Wrist Tendons — Wrist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090393: Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model 72202139,72202141, 72202143, 72202144.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090393
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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