510(k) · Cleared
ClearedSpinewand Surgical Device
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 Sep 28, 2009 as substantially equivalent to K072089 (Arthrocare Corp., 2007) and 1 other predicate after a 154-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Sep 28, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001588 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK001588 Arthrocare System 2000 Controller, Arthrocare System 2000 Cable…Arthrocare Corp. · 2000
- 4 generations backK053297 Arthrocare 8000S Coblator Surgery SystemArthrocare Corp. · 2005
- 3 generations backK060823 Arthrocare WandsArthrocare Corp. · 2006
- 2 generations backK070851 Arthrocare SpinewandsArthrocare Corp. · 2007
- 1 generation backK072089 Arthrocare SpinewandArthrocare Corp. · 2007
- This deviceK091228 Spinewand Surgical DeviceArthrocare Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare… | Arthrocare Corp. | 2000 | — |
| −4 | K053297 | Arthrocare 8000S Coblator Surgery System | Arthrocare Corp. | 2005 | — |
| −3 | K060823 | Arthrocare Wands | Arthrocare Corp. | 2006 | — |
| −2 | K070851 | Arthrocare Spinewands | Arthrocare Corp. | 2007 | — |
| −1 | K072089 | Arthrocare Spinewand | Arthrocare Corp. | 2007 | — |
| 0 (this device) | K091228 | Spinewand Surgical Device | Arthrocare Corp. | 2009 | — |
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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072089 | Arthrocare SpinewandSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare SpineWand K072089 (August 17, 2007) ArthroCare System 2000 KO0 1634 (June 19, 2001) ArthroCare System 2000… | 2007 |
| Kept off the family tree | K001634 | FDA’s K001634 is Cardiosentry Event Monitor, Model 8470-01 Our reading of the summary gave K001634, FDA’s number for Cardiosentry Event Monitor, Model 8470-01 (Tz Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ArthroCare System 2000”. Kept off the family tree. | 2000 |
| * | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…Summary page 1…K072089 (August 17, 2007) ArthroCare System 2000 KO0 1634 (June 19, 2001) ArthroCare System 2000 K001588 (August 17, 2000) Product Description The Wands are bipolar, single use, high frequency electrosurgical devices. Intended Use T… | 2000 |
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 9 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 5 ancestors has a recall.
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 Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091228: Spinewand Surgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091228
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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