# K032406: Stryker RF Electrodes and Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Apr 1, 2004 after 241 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 4 cite it directly.
0 of 23 devices 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.

## Most influential descendants
- K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae (2005), 17 descendants of its own
- 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

## Recalls of this device
- Jun 3, 2024 · Class II · Z-2261-2024: Expired Products distributed to customers
- Jul 17, 2012 · Class II · Z-2134-2012: Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannul
- Jul 17, 2012 · Class II · Z-2135-2012: Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannul

## 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, arthroscopic, 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/K032406
Methodology: https://510kreport.com/methodology