# K033757: MTS Multiprogram Trial Stimulator System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Neuromodulation Systems
- Decided: Jan 30, 2004 after 60 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K123299: MTS System, Wide-Space Quattrode Percutaneous Leads (2013), 0 descendants of its own

## Indications for use
Advanced Neuromodulation Systems, MTS,. Multiprogram Trial Stimulator System is indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The MTS,, Multiprogram Trial Stimulator System is intended to be used with ANS Trial Leads (percutaneous) and External Test Extensions, to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.

Source page: https://510kreport.com/device/K033757
Methodology: https://510kreport.com/methodology