510(k) · Cleared
ClearedAblation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dfine, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 11, 2010 as substantially equivalent to K063172 (Arthrocare Corp., 2007) and 1 other predicate after a 464-day review. Its family tree reaches back 6 generations to 1995. 11 later devices descend from it.
- Decided
- Aug 11, 2010
- Review
- 464 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K943450 (1995). 22 ancestors in all, the oldest K800617 (1980). 11 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 1 generation backK992581 Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord…Arthrocare Corp. · 1999
- This deviceK091310 Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model…Dfine, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK142480 OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK152057 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
- Descendant · 4 generations on · 5 of its ownK182497 OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK221074 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser…Stryker Corporation · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · cites it directly9descendants
- K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015 · 2 generations on8descendants
- K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017 · 3 generations on7descendants
- K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on5descendants
- K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −5 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −1 | K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands… | Arthrocare Corp. | 1999 | — |
| 0 (this device) | K091310 | Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 | Dfine, Inc. | 2010 | — |
| +1 | K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| +2 | K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| +3 | K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017 | — |
| +4 | K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +5 | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Stryker Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K063172 | Arthrocare Cavity SpinewandSummary page 2…ary: The subject device: * Ablation Instrument has the same technological characteristics and principles of operation as its predicate, ArthroCare Cavity SpineWand [K063172, manufactured by ArthroCare Corporation]. The intended use and indications for the Ablation Instrument is a subset of tha… | 2007 |
| * | K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Summary page 2…th the Ablation Instrument) has the same technological characteristics and principles of operation as its predicate, ArthroCare Orthopedic Electrosurgery System [K992581] when used with ArthroCare Cavity SpineWand [K063172, manufactured by ArthroCare Corporation]. The intended use and indic… | 1999 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.2 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K142480 (Baylis Medical Company, Inc., 2015) has gone furthest, with 9 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. 2010, 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 Ablation Instrument is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
The Ablation Generator is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091310 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091310: Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091310
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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