# K182497: OsteoCool RF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jan 15, 2019 after 125 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: 10 generations back to K943450 (1995). 47 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161949: OsteoCool V-3 RF Ablation System, Baylis Medical Company, Inc. (2017) Summary page 4.
- K080451: Uniblate Electrosurgical Device, AngioDynamics, Inc. (2008) Summary page 4.

## Most influential descendants
- 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
- K250327: OptaBlate Radiofrequency (RF) Generator System (2025), 0 descendants of its own
- K223303: Spinery™ RF Ablation System (2023), 0 descendants of its own

## Indications for use
The OsteoCool™ RF Ablation System is intended for: ƒ Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. ƒ Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy. ƒ Ablation of benign bone tumors such as osteoid osteoma.

Source page: https://510kreport.com/device/K182497
Methodology: https://510kreport.com/methodology