# K253656: OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 5, 2026 after 197 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: 12 generations back to K943450 (1995). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233830: OsteoCool™ 2.0 RF Ablation System, Medtronic Sofamor Danek USA, Inc. (2024) Summary page 5.

## Indications for use
▪ Palliative treatment in spinal procedures by ablation of metastatic, malignant lesions in a vertebral body. ▪ 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. ▪ Ablation of benign bone tumors such as osteoid osteoma.

Source page: https://510kreport.com/device/K253656
Methodology: https://510kreport.com/methodology