510(k) · Cleared
Recalled · Class II · 2015Arthrocare Cavity 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 Apr 27, 2007 as substantially equivalent to K001588 (Arthrocare Corp., 2000) and 2 other predicates after a 191-day review. Its family tree reaches back 3 generations to 2000. 12 later devices descend from it. It has been recalled once.
- Decided
- Apr 27, 2007
- Review
- 191 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001588 (2000). 4 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001588 Arthrocare System 2000 Controller, Arthrocare System 2000 Cable…Arthrocare Corp. · 2000
- 2 generations backK053297 Arthrocare 8000S Coblator Surgery SystemArthrocare Corp. · 2005
- 1 generation backK060823 Arthrocare WandsArthrocare Corp. · 2006
- This deviceK063172 Arthrocare Cavity SpinewandArthrocare Corp. · 2007
- 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 · 5 generations on · 5 of its ownK182497 OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · 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
- K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare… | Arthrocare Corp. | 2000 | — |
| −2 | K053297 | Arthrocare 8000S Coblator Surgery System | Arthrocare Corp. | 2005 | — |
| −1 | K060823 | Arthrocare Wands | Arthrocare Corp. | 2006 | — |
| 0 (this device) | K063172 | Arthrocare Cavity Spinewand | Arthrocare Corp. | 2007 | — |
| +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 | — |
| +5 | K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…Summary page 1…urgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare* Wands K001588 and K060823 RITA System K040989 Product Description The ArthroCare Cavity SpineWands are bipolar, si… | 2000 |
| * | K060823 | Arthrocare WandsSummary page 1…ing and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare* Wands K001588 and K060823 RITA System K040989 Product Description The ArthroCare Cavity SpineWands are bipolar, single use, hi… | 2006 |
| * | K040989 | Rita SystemsSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare* Wands K001588 and K060823 RITA System K040989 Product Description The ArthroCare Cavity SpineWands are bipolar, single use, high frequency electrosurgical devices designed f… | 2004 |
What descends from it? (12)
See all 121 later device cites 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 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2015 | Class II | Z-0623-2016 | Under Investigation by firm | There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier. |
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.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K091310 (Dfine, Inc., 2010) has gone furthest, with 11 descendants of its own.
- 7 other devices also cite its predicate K001588.
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 ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063172 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063172: Arthrocare Cavity Spinewand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063172
Report an extraction error
Are you the manufacturer?
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