# K071482: Stryker RF Multi-Lesion Generator, Model 0406-900-000

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Dec 20, 2007 after 204 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032601 (2004). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032601: Stryker Interventional Pain RF Generator, Valley Forge Scientific Corp. (2004) Summary page 1.
- K052878: NT-1000, Neuro Therm, Inc. (2006) Summary page 1.

## Most influential descendants
- K111576: NT 2000 Lesioning Generator (2011), 3 descendants of its own
- K232632: Racz Neurostat RF Generator (2024), 0 descendants of its own
- K220122: APEX 6 (2023), 0 descendants of its own
- K201610: IonicRF Generator (2020), 0 descendants of its own
- K170242: MultiGen™ 2 RF Generator System (2017), 0 descendants of its own

## Recalls of this device
- Oct 11, 2016 · Class III · Z-0584-2017: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained

## Indications for use
The Stiyker RE Multi-Lesion Generator, in combination with the Stryker RF Electrodes and Cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Exmnples include, but are not limited to: Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. The Sthyker RE Muli-Lesion Generator in combination with a Smith & Nephew SPINECATiTM &Acuthe'mnTM catheters are intended for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

Source page: https://510kreport.com/device/K071482
Methodology: https://510kreport.com/methodology