# K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: May 31, 2005 after 168 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991218 (1999). 8 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032406: Stryker RF Electrodes and Cannulae, Stryker Instruments (2004) Summary page 1.
- K032601: Stryker Interventional Pain RF Generator, Valley Forge Scientific Corp. (2004) Summary page 1.
- K896450: Neuro N 50 Lesion Generator, Leibinger & Fischer, Ltd. (1991) Summary page 1.
- K002389: Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay, Baylis Medical Co., Inc. (2000) Summary page 1.
- K031371: Saphyre Bipolar Ablation Probes, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (2016), 7 descendants of its own
- K061660: Stryker RF Parallel Bipolar Adaptor Cable (2006), 5 descendants of its own
- K180369: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (2018), 4 descendants of its own
- K170827: INTRACEPT Intraosseous Nerve Ablation System (2017), 4 descendants of its own
- K083528: Smith & Nephew Bipolar Adapter Cable, Model 72200022 (2009), 4 descendants of its own

## Indications for use
The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. They are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the spinal cord, peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Source page: https://510kreport.com/device/K043442
Methodology: https://510kreport.com/methodology