510(k) · Cleared
ClearedArthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands
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 Dec 9, 1999 as substantially equivalent to K943450 (Arthrocare Corp., 1995) and 3 other predicates after a 129-day review. Its family tree reaches back 5 generations to 1995. 23 later devices descend from it.
- Decided
- Dec 9, 1999
- Review
- 129 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K943450 (1995). 16 ancestors in all, the oldest K800617 (1980). 23 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 4 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 2 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 1 generation backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- This deviceK992581 Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord…Arthrocare Corp. · 1999
- Descendant · cites it directly · 11 of its ownK091310 Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model…Dfine, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK142480 OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK152057 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- Descendant · 4 generations on · 7 of its ownK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK033547 Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc. · 2010 · cites it directly11descendants
- K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · 2 generations on9descendants
- K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · 3 generations on8descendants
- K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017 · 4 generations on7descendants
- K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −4 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −2 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −1 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| 0 (this device) | K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands… | Arthrocare Corp. | 1999 | — |
| +1 | K091310 | Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 | Dfine, Inc. | 2010 | — |
| +2 | K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| +3 | K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| +4 | K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017 | — |
| +1 | K033547 | Vnus Vessel and Tissue Coagulation System | Vnus Medical Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970Summary page 1…oCare Orthopedic Electrosurgery System Generic/Common Name: Electrosurgical Device and Accessories Predicate Devices ArthroCare Arthroscopic Electrosurgery System 970 K943450 ArthroCare Arthroscopic Electrosurgery System 980 (Model 2000) K963123 ArthroCare ENTec Surgery System K973478 Ellman Surgitron K… | 1995 |
| * | K963123 | Arthrocare Arthroscopic Eletrosurgery System (Model 980)Summary page 1…gical Device and Accessories Predicate Devices ArthroCare Arthroscopic Electrosurgery System 970 K943450 ArthroCare Arthroscopic Electrosurgery System 980 (Model 2000) K963123 ArthroCare ENTec Surgery System K973478 Ellman Surgitron K980170 Intended Use The ArthroCare Orthopedic Electrosurgery System is… | 1996 |
| * | K973478 | Arthrocare Sinus Electrosurgery SystemSummary page 1…Devices ArthroCare Arthroscopic Electrosurgery System 970 K943450 ArthroCare Arthroscopic Electrosurgery System 980 (Model 2000) K963123 ArthroCare ENTec Surgery System K973478 Ellman Surgitron K980170 Intended Use The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and… | 1998 |
| * | K980170 | SurgitronSummary page 1…oscopic Electrosurgery System 970 K943450 ArthroCare Arthroscopic Electrosurgery System 980 (Model 2000) K963123 ArthroCare ENTec Surgery System K973478 Ellman Surgitron K980170 Intended Use The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissu… | 1998 |
What descends from it? (23)
See all 235 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091310 | Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 | 2010 | 11 |
| K033547 | Vnus Vessel and Tissue Coagulation System | 2004 | 6 |
| K012631 | Reprocessed Soft Tissue Ablators | 2001 | 1 |
| K012679 | Reprocessed RF Arthroscopy Probes | 2001 | 0 |
| K012129 | Ortho Development Orion-I Emf System | 2001 | 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 4 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K091310 (Dfine, Inc., 2010) has gone furthest, with 11 descendants of its own.
- 10 other devices also cite its predicate K943450.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992581 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992581: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992581
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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