# K052418: Axxess Butterfly Anchor

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation Systems
- Decided: Sep 26, 2005 after 24 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Axxess® Butterfly Anchor accessory is intended to be used with the ANS Axxess percutaneous permanent and trial leads to secure the leads to the interspinous ligament.

Source page: https://510kreport.com/device/K052418
Methodology: https://510kreport.com/methodology