# K250327: OptaBlate Radiofrequency (RF) Generator System

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Apr 15, 2025 after 69 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)
- K221074: OptaBlate RF Generator, OptaBlate  Probes, OptaBlate Microinfuser Infusion Device, Stryker Corporation (2022) Summary page 5.

## 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 standards therapy. • Ablation of benign bone tumors such as osteoid osteoma.

Source page: https://510kreport.com/device/K250327
Methodology: https://510kreport.com/methodology