# K123299: MTS System, Wide-Space Quattrode Percutaneous Leads

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical Neuromodulation
- Decided: Jan 18, 2013 after 87 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033757 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033757: MTS Multiprogram Trial Stimulator System, Advanced Neuromodulation Systems (2004) Summary page 1.
- K072462: Wide Spaced Quattrode Leads, Advanced Neuromodulation Systems (2007) Summary page 1.

## Recalls of this device
- Jul 29, 2014 · Class II · Z-2719-2014: The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrec
- Jul 29, 2014 · Class II · Z-2718-2014: The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrec

## Indications for use
The 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 Multiprogram Trial Stimulator System is intended to be used with St. Jude Medical Neuromodulation Division percutaneous trial leads and external test extensions to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or postoperatively for up to a maximum of 30 days. The St. Jude medical Neuromodulation Division neurostimulation systems are indicated for spinal cord stimulation (SCS) in 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. St. Jude Medical Neuromodulation Division percutaneous leads model numbers 3066, 3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341, 3342, 3343, and receiver model number 3408, transmitter model number 3508 and antenna model numbers 1220 and 1230 are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.

Source page: https://510kreport.com/device/K123299
Methodology: https://510kreport.com/methodology