# K211965: StimRouter Neuromodulation System

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: Feb 23, 2022 after 244 days
- Product code: GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K142432 (2015). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200482: StimRouter Neuromodulation System, Bioness, Inc. (2020) Summary page 5.

## Most influential descendants
- K243782: StimTrial Neuromodulation System (2025), 0 descendants of its own
- K243678: TalisMann Neuromodulation System (2025), 0 descendants of its own

## Indications for use
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Source page: https://510kreport.com/device/K211965
Methodology: https://510kreport.com/methodology