510(k) · Cleared
ClearedArthrex Synergy RF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 9, 2016 as substantially equivalent to K082666 (Arthrocare Corp., 2008) after a 93-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Sep 9, 2016
- Review
- 93 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011083 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK161581 Arthrex Synergy RF SystemArthrex, Inc. · 2016
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) | K161581 | Arthrex Synergy RF System | Arthrex, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Summary page 4…-frequency electrical current. Classification Class II Review Panel General & Plastic Surgery Predicate Devices ArthroCare System 12000 (K082666) Purpose of Submission This traditional 510(k) premarket notification is submitted to obtain clearance… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 8 ancestors has a recall of any class.
- 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. 2016, 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 Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. The RF Probe are…
Read the full statement (132 words)
The Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.
The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.
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/K161581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161581: Arthrex Synergy RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161581
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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