# K221074: OptaBlate RF Generator, OptaBlate  Probes, OptaBlate Microinfuser Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Sep 16, 2022 after 157 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: 11 generations back to K943450 (1995). 48 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182497: OsteoCool RF Ablation System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4.

## Most influential descendants
- 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 intended use of the OptaBlate™ Radiofrequency (RF) Generator System is as follows: » 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/K221074
Methodology: https://510kreport.com/methodology