510(k) · Cleared
Recalled · Class II · 2016Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00, H4000-00;
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 Feb 15, 2008 as substantially equivalent to K053567 (Arthrocare Corp., 2006) and 1 other predicate after an 11-day review. Its family tree reaches back 8 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 15, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K011083 (2001). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 7 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 6 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 5 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 4 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 3 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 2 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 1 generation backK053567 Athrocare Topaz ArthrowandsArthrocare Corp. · 2006 · Recalled
- This deviceK080282 Arthrocare Controllers (System 2000,1100,1200), Model H2076-00…Arthrocare Corp. · 2008
- Descendant · cites it directly · 0 of its ownK140521 Topaz EZ Microdebrider Coblation Wand with Integrated Finger SwitchArthroCare Corporation · 2014
Most influential descendants
Showing 1 of 1 · See all- K140521Topaz EZ Microdebrider Coblation Wand with Integrated Finger SwitchArthroCare Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −7 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −6 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −5 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −4 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −3 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −2 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −1 | K053567 | Athrocare Topaz Arthrowands | Arthrocare Corp. | 2006 | 1 |
| 0 (this device) | K080282 | Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00… | Arthrocare Corp. | 2008 | — |
| +1 | K140521 | Topaz EZ Microdebrider Coblation Wand with Integrated Finger Switch | ArthroCare Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K053567 | Athrocare Topaz ArthrowandsSummary page 1…utting and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare® Topaz® Arthiro Wandsg K053567 ArtliroCare System 12000 K07 1709 Product Description The ArthroCare Topaz ArthroWands are bipolar, single us… | 2006 |
| * | K071709 | Arthrocare System 12000Summary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare® Topaz® Arthiro Wandsg K053567 ArtliroCare System 12000 K07 1709 Product Description The ArthroCare Topaz ArthroWands are bipolar, single use, high frequency electrosurgical devices designed fo… | 2007 |
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 |
|---|---|---|---|
| K140521 | Topaz EZ Microdebrider Coblation Wand with Integrated Finger Switch | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2016 | Class II | Z-1321-2016 | Package design/selection | During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels. |
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 5 months on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K140521 (ArthroCare Corporation, 2014) has gone furthest, with 0 descendants of its own.
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 Topaz ArthroWands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
* Fasciotomy — Foot
* Synovectomy — Foot
* Tendonotomy — Knee, Wrist, Elbow, Ankle, Shoulder, Foot
* Rotator Cuff Tendonotomy — Shoulder
* Capsulotomy — Foot
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080282: Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00, H4000-00;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080282
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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