510(k) · Cleared
Recalled · Class II · 2015Arthroscopic Energy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 23, 2014 as substantially equivalent to K082666 (Arthrocare Corp., 2008) and 1 other predicate after a 139-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 23, 2014
- Review
- 139 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K011083 (2001). 13 ancestors in all, the oldest K905654 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 6 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 5 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 4 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 3 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 2 generations backK071709 Arthrocare System 12000Arthrocare Corp. · 2007
- 1 generation backK082666 Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot…Arthrocare Corp. · 2008
- This deviceK140578 Arthroscopic Energy SystemConmed Corporation · 2014
- Descendant · cites it directly · 0 of its ownK153499 EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes…Conmed Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy…Conmed Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −6 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −5 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −3 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −2 | K071709 | Arthrocare System 12000 | Arthrocare Corp. | 2007 | — |
| −1 | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control… | Arthrocare Corp. | 2008 | — |
| 0 (this device) | K140578 | Arthroscopic Energy System | Conmed Corporation | 2014 | — |
| +1 | K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes… | Conmed Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Summary page 1…edicate/Legally Marketed Devices Device Name: ArthroCareg® System 12000 Company Name: ArthroCare Corporation 5 10O(k) #: K082666 Device Name: ConMed Sabre Genesis Electrosurgical Generator Company Name: ConMed Electrosurgery… | 2008 |
| * | K103665 | Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical…Summary page 1…K082666 Device Name: ConMed Sabre Genesis Electrosurgical Generator Company Name: ConMed Electrosurgery 5 10(k)# K103665 Page 1 of 3 - CoNMED… | 2011 |
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 |
|---|---|---|---|
| K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2015 | Class II | Z-0205-2016 | Software design (manufacturing process) | Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K153499 (Conmed Corporation, 2015) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K082666.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Arthroscopic Energy™ System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140578: Arthroscopic Energy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140578
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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