510(k) Report

510(k) · Cleared

Cleared

Medtronic Mattrix 3271/3272 Neurostimulation System

K934065510(k) TraditionalCleared Feb 14, 1995543-day reviewClass II21 CFR 882.5880

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Cleared on Feb 14, 1995 after a 543-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 27 later devices descend from it.

Decided
Feb 14, 1995
Review
543 days
Class
Class II
Product code
GZB
Recalls
None
Predicates
0

27 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2016: 3 descendants cleared2015: 1 descendant cleared2004: 1 descendant cleared1997: 1 descendant cleared2020: 3 descendants cleared2017: 2 descendants cleared2024: 3 descendants cleared2019: 5 descendants cleared2018: 1 descendant cleared2025: 2 descendants cleared2021: 2 descendants cleared2023: 1 descendant cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK934065 Medtronic Mattrix 3271/3272 Neurostimulation SystemMedtronic Vascular · 1995
  2. Descendant · cites it directly · 24 of its ownK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
  3. Descendant · cites it directly · 23 of its ownK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
  4. Descendant · 2 generations on · 21 of its ownK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
  5. Descendant · 2 generations on · 20 of its ownK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
  6. Descendant · 3 generations on · 19 of its ownK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1997: 12004: 12014: 12015: 12016: 32017: 22018: 12019: 52020: 32021: 22022: 12023: 12024: 32025: 2
1997high 5 (2019) · low 0 (1998)2026

Most influential descendants

Showing 5 of 27 · See all
  • K141399Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014 · cites it directly24descendants
  • K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015 · cites it directly23descendants
  • K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016 · 2 generations on21descendants
  • K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…Stimwave Technologies Incorporated · 2016 · 2 generations on20descendants
  • K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…Stimwave Technologies Incorporated · 2017 · 3 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934065Medtronic Mattrix 3271/3272 Neurostimulation SystemMedtronic Vascular1995—
+1K141399Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated2014—
+1K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2015—
+2K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2016—
+2K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable…Stimwave Technologies Incorporated2016—
+3K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable…Stimwave Technologies Incorporated2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200410
201410
201510
201630
201720
201810
201950
202030
202120
202210
202310
202430
202520
FIG. 1 — Lineage of K934065, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (27)

See all 27

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141399Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated201424
K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated201523
K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC201610
K040568Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular20040
K972043Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 ScreenerMedtronic Vascular19970

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K141399 (Stimwave Technologies Incorporated, 2014) has gone furthest, with 24 descendants of its own.

How does its category compare?

All GZB devices

GZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZB

1in 2024

2007: 22008: 12009: 32010: 12011: 42012: 22013: 22014: 22015: 22016: 22017: 22018: 12019: 42020: 22021: 12022: 12024: 1
2007high 4 (2011) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZB

149in 2019

2009: 62 days median2011: 67 days median2019: 149 days median
2007high 149 (2019) · low 62 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZB

1in 2010

2008: 12010: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZB

313in 2025

2007: 2012008: 682009: 592010: 1572011: 4712012: 1,0902013: 4,4282014: 10,8492015: 7,5072016: 4,5562017: 5,5112018: 5,2442019: 6432020: 4662021: 3322022: 2092023: 2362024: 3182025: 313
2007high 10,849 (2014) · low 59 (2009)2025

MAUDE reports naming product code GZB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0201
20081—168
2009362059
20101—1157
20114670471
20122—01,090
20132—04,428
20142—010,849
20152—07,507
20162—04,556
20172—05,511
20181—05,244
201941490643
20202—0466
20211—0332
20221—0209
20230—0236
20241—0318
20250—0313
20260—1—

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1,057 FDA decisions under this applicant name. See the company

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Recent decisions in GZB

The GZB category page

  • K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve…Boston Scientific Neuromodulation · 20241 recall
  • K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2022
  • K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2021
  • K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em…Boston Scientific Neuromodulation · 2020
  • K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020

https://510kreport.com/device/K934065 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934065: Medtronic Mattrix 3271/3272 Neurostimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934065

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026