# K253877: StimTrial Neuromodulation System

- Pathway: 510(k) (Special)
- Applicant: Bioventus, LLC
- Decided: Aug 26, 2026 after 265 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The StimTrial System is indicated for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for either the StimRouter Neuromodulation System’s or the TalisMann Neuromodulation System’s permanent (long term) implant indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain in the craniofacial region.

Source page: https://510kreport.com/device/K253877
Methodology: https://510kreport.com/methodology