Devices

FDA-cleared peripheral nerve stimulation lead with an integrated receiver driven by an external transmitter, latest 510(k) read cleared February 2022. Thin: 510(k) text only.

Catalog specification sheet - Peripheral nerve

Bioness StimRouter PNS

Primary source →

Record ID
BTSD-FDA-0024
Reviewed
2026-10-08
Interface
pni
Evidence stage
human

Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.

Bioness StimRouter PNS

StimRouter is an implanted peripheral nerve lead with an integrated receiver, driven by an external pulse transmitter worn on a skin patch. This sheet uses the 510(k) K211965 clearance. Lead and waveform specs are Unreported.

Identity

FieldValue and source scope
DeviceBioness StimRouter Neuromodulation System: implantable multi-electrode lead with integrated receiver, external pulse transmitter on a hydrogel electrode patch, clinician programmer, stimulation tester and patient wireless control [1]
ManufacturerBioness Inc., Valencia, California [1]
Interface classImplanted peripheral nerve lead powered and driven transcutaneously by an external transmitter [1]
OriginCommercial FDA-cleared device; 510(k) K211965, predicate K200482 [1]
First demonstratedUnreported
First human implantUnreported
Species studiedHuman [1]
Regulatory status510(k) K211965 cleared February 22, 2022 (dated January 21, 2022); predicate K200482 cleared 2020; Class II, 21 CFR 882.5870, product code GZF [1][2]
FunctionElectrical stimulation of a target peripheral nerve for severe intractable chronic pain of peripheral nerve origin, as an adjunct to other therapies; not for craniofacial pain [1]
Target tissuePeripheral nerve [1]

Geometry and architecture

FieldValue and source scope
Interface typeImplantable multi-electrode lead with an integrated receiver; supplied in a Lead Loader for intraoperative testing [1]
Array layoutUnreported
Electrode countUnreported
PitchUnreported
Electrode lengthsUnreported
Shank width and thicknessUnreported
Tip and exposed site geometryUnreported
Contact coatingUnreported
InsulationUnreported
Insertion methodUnreported
Anchoring and fixationUnreported

Electrode and channel physics

FieldValue and source scope
Exposed site areaUnreported
Electrode materialUnreported
Impedance (with measurement frequency)Unreported
Noise floor or SNRUnreported
Recording modalityUnreported
Sampling rateUnreported
Stimulation capabilityUnreported
Charge injection limitUnreported
Reference and groundUnreported

Tissue interface and bioresponse

FieldValue and source scope
Target tissueUnreported
Insertion trauma and BBB disruptionUnreported
Vascular disruption riskUnreported
Micromotion sensitivityUnreported
Gliosis and encapsulationUnreported
Neuron loss near sitesUnreported
Foreign-body response mitigationUnreported
Typical failure modesUnreported

System architecture

FieldValue and source scope
Onboard electronicsUnreported
Data pathThe external pulse transmitter on a skin electrode patch sends an electrical signal transcutaneously to the lead’s receiver [1]
Telemetry bandwidthUnreported
Sampling rateUnreported
PowerNo implanted battery described; stimulation energy comes from the external transmitter [1]
Thermal managementUnreported
Packaging and hermeticityUnreported
MRI compatibilityUnreported
Surgical complexityUnreported
Output connectorsUnreported

Performance envelope

FieldValue and source scope
Acute yieldUnreported
Chronic yieldUnreported
Stability over timeUnreported
LongevityUnreported
Revision and explant experienceUnreported
Adverse eventsUnreported
Notable demonstrationsUnreported

Clinical and preclinical evidence

FieldValue and source scope
Human subjectsUnreported
Preclinical cohortUnreported
Follow-up durationUnreported
IndicationsAdults with severe intractable chronic pain of peripheral nerve origin as an adjunct to other modes of therapy such as medications [1]
Trials and registriesUnreported
Primary outcomesUnreported
Key limitations510(k) clearance letter and summary only; lead length, electrode count, waveform and clinical data were not extracted, so they read Unreported [1]

Engineering tradeoffs

FieldValue and source scope
StrengthsUnreported
LimitationsUnreported
Scaling constraintsUnreported

Version boundary

K211965 is the latest StimRouter clearance read. Earlier clearances K190047, K142432 and K200482 are not described.

References

  1. FDA 510(k) clearance and summary, K211965.
  2. FDA 510(k) clearance letter, K200482.