510(k) · Cleared
Recalled · Class II · 2014MTS System, Wide-Space Quattrode Percutaneous Leads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical Neuromodulation · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Jan 18, 2013 as substantially equivalent to K033757 (Advanced Neuromodulation Systems, 2004) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 2004. It has been recalled 2 times.
- Decided
- Jan 18, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- GZB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033757 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK033757 MTS Multiprogram Trial Stimulator SystemAdvanced Neuromodulation Systems · 2004
- This deviceK123299 MTS System, Wide-Space Quattrode Percutaneous LeadsSt. Jude Medical Neuromodulation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033757 | MTS Multiprogram Trial Stimulator System | Advanced Neuromodulation Systems | 2004 | — |
| 0 (this device) | K123299 | MTS System, Wide-Space Quattrode Percutaneous Leads | St. Jude Medical Neuromodulation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZB device
- #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033757 | MTS Multiprogram Trial Stimulator SystemSummary page 1…n Relief (21 CFR 882.5870) Predicate Device Names> MTSTM Multiprogram Trial Stimulator System (K033757) Wide-Spaced QuattrodeTm Leads (K072462) Establishment Registration Numb… | 2004 |
| * | K072462 | Wide Spaced Quattrode LeadsSummary page 1…ate Device Names> MTSTM Multiprogram Trial Stimulator System (K033757) Wide-Spaced QuattrodeTm Leads (K072462) Establishment Registration Number: 1627487 Device Description MIS M System The MSTM System (… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2014 | Class II | Z-2719-2014 | Packaging process control | 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 incorrect international manuals. |
| Jul 29, 2014 | Class II | Z-2718-2014 | Packaging process control | 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 incorrect international manuals. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All GZB devicesGZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GZB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GZB
149in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZB
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZB
313in 2025
MAUDE reports naming product code GZB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 201 |
| 2008 | 1 | — | 1 | 68 |
| 2009 | 3 | 62 | 0 | 59 |
| 2010 | 1 | — | 1 | 157 |
| 2011 | 4 | 67 | 0 | 471 |
| 2012 | 2 | — | 0 | 1,090 |
| 2013 | 2 | — | 0 | 4,428 |
| 2014 | 2 | — | 0 | 10,849 |
| 2015 | 2 | — | 0 | 7,507 |
| 2016 | 2 | — | 0 | 4,556 |
| 2017 | 2 | — | 0 | 5,511 |
| 2018 | 1 | — | 0 | 5,244 |
| 2019 | 4 | 149 | 0 | 643 |
| 2020 | 2 | — | 0 | 466 |
| 2021 | 1 | — | 0 | 332 |
| 2022 | 1 | — | 0 | 209 |
| 2023 | 0 | — | 0 | 236 |
| 2024 | 1 | — | 0 | 318 |
| 2025 | 0 | — | 0 | 313 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (183 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123299: MTS System, Wide-Space Quattrode Percutaneous Leads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123299
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026