# K111523: Osteocool (TM) RF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Mar 13, 2012 after 286 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: 7 generations back to K943450 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040989: Rita Systems, Rita Medical Systems (2004) Summary page 1.
- K091310: Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682, Dfine, Inc. (2010) Summary page 1.

## Indications for use
The OsteoCoolTM RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body in patients who have failed or are not candidates for standard pain therapy.

Source page: https://510kreport.com/device/K111523
Methodology: https://510kreport.com/methodology