510(k) · Cleared
ClearedArthrocare Spinewand
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 Aug 17, 2007 as substantially equivalent to K070851 (Arthrocare Corp., 2007) and 2 other predicates after an 18-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Aug 17, 2007
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K001588 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001588 Arthrocare System 2000 Controller, Arthrocare System 2000 Cable…Arthrocare Corp. · 2000
- 3 generations backK053297 Arthrocare 8000S Coblator Surgery SystemArthrocare Corp. · 2005
- 2 generations backK060823 Arthrocare WandsArthrocare Corp. · 2006
- 1 generation backK070851 Arthrocare SpinewandsArthrocare Corp. · 2007
- This deviceK072089 Arthrocare SpinewandArthrocare Corp. · 2007
- Descendant · cites it directly · 0 of its ownK091228 Spinewand Surgical DeviceArthrocare Corp. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091228Spinewand Surgical DeviceArthrocare Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare… | Arthrocare Corp. | 2000 | — |
| −3 | K053297 | Arthrocare 8000S Coblator Surgery System | Arthrocare Corp. | 2005 | — |
| −2 | K060823 | Arthrocare Wands | Arthrocare Corp. | 2006 | — |
| −1 | K070851 | Arthrocare Spinewands | Arthrocare Corp. | 2007 | — |
| 0 (this device) | K072089 | Arthrocare Spinewand | Arthrocare Corp. | 2007 | — |
| +1 | K091228 | Spinewand Surgical Device | Arthrocare Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070851 | Arthrocare SpinewandsSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare SpineWand K070851 (April 13, 2007) ArthroCare Wand K060823 (April 10, 2006) ArthroCare System 2000… | 2007 |
| * | K060823 | Arthrocare WandsSummary page 1…878.4400) Predicate Devices ArthroCare SpineWand K070851 (April 13, 2007) ArthroCare Wand K060823 (April 10, 2006) ArthroCare System 2000 K001588 (August 17, 2000) Product Description The Wands are b… | 2006 |
| * | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…Summary page 1…K070851 (April 13, 2007) ArthroCare Wand K060823 (April 10, 2006) ArthroCare System 2000 K001588 (August 17, 2000) Product Description The Wands are bipolar, single use, high frequency electrosurgical devices. Intended Use… | 2000 |
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 |
|---|---|---|---|
| K091228 | Spinewand Surgical Device | 2009 | 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 7 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K091228 (Arthrocare Corp., 2009) 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. 2007, 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/K072089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072089: Arthrocare Spinewand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072089
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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