# K152057: OsteoCool V-3 RF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Nov 24, 2015 after 123 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943450 (1995). 24 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142480: OsteoCool V-2 RF Ablation System, Baylis Medical Company, Inc. (2015) Summary page 4.

## Most influential descendants
- K161949: OsteoCool V-3 RF Ablation System (2017), 7 descendants of its own
- K182497: OsteoCool RF Ablation System (2019), 5 descendants of its own
- K221074: OptaBlate RF Generator, OptaBlate  Probes, OptaBlate Microinfuser Infusion Device (2022), 2 descendants of its own
- K233830: OsteoCool™ 2.0 RF Ablation System (2024), 1 descendant of its own
- K253656: OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K152057
Methodology: https://510kreport.com/methodology