510(k) Report

510(k) · Cleared

Cleared

Lamitrode Leads

K990469510(k) TraditionalCleared Jun 3, 1999107-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

Advanced Neuromodulation Systems · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Cleared on Jun 3, 1999 as substantially equivalent to K853643 (Neuromed, Inc., 1985) and 5 other predicates after a 107-day review. Its family tree reaches back 2 generations to 1981.

Decided
Jun 3, 1999
Review
107 days
Class
Class II
Product code
GZB
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K810182 (1981). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 2 other ancestors1989: 1 other ancestor1985: 1 other ancestor1981: 1 other ancestor1986: 1 other ancestorK810182 · Programmable Spinal Coral Stim. System · Electronic Diagnostics, Inc. · 1981K960728 · One Step Connect Leads (Quattrode, Octrode, Cervitrode) · Neuromed, Inc. · 199619801985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor K960728 · One Step Connect Leads (Quattrode, Octrode, Cervitrode) · Neuromed, Inc. · 1996K810182 · Programmable Spinal Coral Stim. System · Electronic Diagnostics, Inc. · 19810
  1. Root · 2 generations backK810182 Programmable Spinal Coral Stim. SystemElectronic Diagnostics, Inc. · 1981
  2. 1 generation backK960728 One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc. · 1996
  3. This deviceK990469 Lamitrode LeadsAdvanced Neuromodulation Systems · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K810182Programmable Spinal Coral Stim. SystemElectronic Diagnostics, Inc.1981—
−1K960728One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc.1996—
0 (this device)K990469Lamitrode LeadsAdvanced Neuromodulation Systems1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198510
198610
198910
199120
FIG. 1 — Lineage of K990469, 1981–1999Source: 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), 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. #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? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K853643Multistim Laminectomy Electrode
Summary page 2
…or Pain Relief Predicate Device: Advanced Neuromodulation Systems, Inc.,., currently markets spinal cord stimulator systems with Silicone lead insulators under 510(k) # K853643 and K905255 and K960728. Device Description: Advanced Neuromodulation Systems, Inc.’s Lamitrode Leads are implantable devices co…
Neuromed, Inc.1985—
*K905255Neuromed Model 1992 LS Lamitrode Lead
Summary page 2
…ef Predicate Device: Advanced Neuromodulation Systems, Inc.,., currently markets spinal cord stimulator systems with Silicone lead insulators under 510(k) # K853643 and K905255 and K960728. Device Description: Advanced Neuromodulation Systems, Inc.’s Lamitrode Leads are implantable devices consisting of…
Neuromed, Inc.1991—
*K960728One Step Connect Leads (Quattrode, Octrode, Cervitrode)
Summary page 2
…e Device: Advanced Neuromodulation Systems, Inc.,., currently markets spinal cord stimulator systems with Silicone lead insulators under 510(k) # K853643 and K905255 and K960728. Device Description: Advanced Neuromodulation Systems, Inc.’s Lamitrode Leads are implantable devices consisting of spaced elect…
Neuromed, Inc.1996—
*K884948Model 3587A Resume Epidural Lead
Summary page 3
…EXAS 75002 / 972 390-9800 / FAX: 972 390-2881 HANS Page 3 of 3 ANS Predicate Device 510(k) K853643, K905255, K960728 Medtronic Predicate Device 510(k} K884948, K811655, and K905407 ANS Modified Device K# Under Review Intended Use: Stimulation of spinal cord for treatment of chronic pa…
Medtronic Vascular1989—
*K811655Myelostat Dorsal Cord Stimulator
Summary page 3
…2 / 972 390-9800 / FAX: 972 390-2881 HANS Page 3 of 3 ANS Predicate Device 510(k) K853643, K905255, K960728 Medtronic Predicate Device 510(k} K884948, K811655, and K905407 ANS Modified Device K# Under Review Intended Use: Stimulation of spinal cord for treatment of chronic pain of the…
Medtronic Vascular1981—
*K905407Model 3487A Pisces-Quad,3587A Resume,3586 Resume
Summary page 3
…800 / FAX: 972 390-2881 HANS Page 3 of 3 ANS Predicate Device 510(k) K853643, K905255, K960728 Medtronic Predicate Device 510(k} K884948, K811655, and K905407 ANS Modified Device K# Under Review Intended Use: Stimulation of spinal cord for treatment of chronic pain of the trunk and li…
Medtronic Vascular1991—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
  • None of the 8 ancestors has a recall.

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—

What is it indicated for?

Advanced Neuromodulation Systems Lamitrode Spinal Cord Stimulation Leads are 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 and is intended to be used with Advanced Neuromodulation Systems extensions and/or receivers, transmitters, and antennae. The proposed device modification does not affect the original intended use of the legally marketed device.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Advanced Neuromodulation Systems

25 FDA decisions under this applicant name. See the company

  • K092371Swift-Lock Anchor, Model 1192Advanced Neuromodulation Systems · 20091 recall
  • K090907Penta Lead Kits, Models: 3227-3234Advanced Neuromodulation Systems · 2009
  • K081208Cinch Anchor, Model 1194Advanced Neuromodulation Systems · 2008
  • K072462Wide Spaced Quattrode LeadsAdvanced Neuromodulation Systems · 2007
  • K070847Trial Cable, 3009Advanced Neuromodulation Systems · 2007

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/K990469 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990469: Lamitrode Leads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990469

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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