510(k) · Cleared
ClearedOsteoCool V-3 RF Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 24, 2015 as substantially equivalent to K142480 (Baylis Medical Company, Inc., 2015) after a 123-day review. Its family tree reaches back 8 generations to 1995. 8 later devices descend from it.
- Decided
- Nov 24, 2015
- Review
- 123 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K943450 (1995). 24 ancestors in all, the oldest K800617 (1980). 8 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 3 generations backK992581 Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord…Arthrocare Corp. · 1999
- 2 generations backK091310 Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model…Dfine, Inc. · 2010
- 1 generation backK142480 OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- This deviceK152057 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK182497 OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK221074 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser…Stryker Corporation · 2022
- Descendant · 3 generations on · 1 of its ownK233830 OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK253656 OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017 · cites it directly7descendants
- K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on5descendants
- K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022 · 3 generations on2descendants
- K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2024 · 3 generations on1descendant
- K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −3 | K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands… | Arthrocare Corp. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| +1 | K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017 | — |
| +2 | K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Stryker Corporation | 2022 | — |
| +3 | K233830 | OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
| +4 | K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142480 | OsteoCool V-2 RF Ablation SystemSummary page 4…dicate Device Table 7.1: Predicate Device Predicate Device Manufacturer 510(k) OsteoCool V-2 RF Ablation Baylis Medical Company Inc. K142480 System Traditional 510(k) VOL_007-Page 1 OsteoCool® V-3 RF Ablatio… | 2015 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161949 | OsteoCool V-3 RF Ablation System | 2017 | 7 |
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 20 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K161949 (Baylis Medical Company, Inc., 2017) has gone furthest, with 7 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. 2015, 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 OsteoCool® V-3 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
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/K152057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152057: OsteoCool V-3 RF Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152057
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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