# K243678: TalisMann Neuromodulation System

- Pathway: 510(k) (Traditional)
- Applicant: Bioventus, LLC
- Decided: Jul 3, 2025 after 218 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: 8 generations back to K883780 (1988). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211965: StimRouter Neuromodulation System, Bioness, Inc. (2022) Summary page 5.
- K183579: Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits, Boston Scientific Neuromodulation (2019) Summary page 5.
- K000852: Renew Neurostimulation System, Advanced Neuromodulation Systems (2001) Summary page 5.

## Indications for use
The TalisMann 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 TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.

Source page: https://510kreport.com/device/K243678
Methodology: https://510kreport.com/methodology