510(k) · Cleared
ClearedRenew Lead Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Neuromodulation Systems · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Jun 24, 1999 as substantially equivalent to K960728 (Neuromed, Inc., 1996) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Jun 24, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810182 (1981). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK810182 Programmable Spinal Coral Stim. SystemElectronic Diagnostics, Inc. · 1981
- 1 generation backK960728 One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc. · 1996
- This deviceK991784 Renew Lead ExtensionAdvanced Neuromodulation Systems · 1999
- Descendant · cites it directly · 0 of its ownK992946 Renew ReceiverAdvanced Neuromodulation Systems · 1999
Most influential descendants
Showing 1 of 1 · See all- K992946Renew ReceiverAdvanced Neuromodulation Systems · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810182 | Programmable Spinal Coral Stim. System | Electronic Diagnostics, Inc. | 1981 | — |
| −1 | K960728 | One Step Connect Leads (Quattrode, Octrode, Cervitrode) | Neuromed, Inc. | 1996 | — |
| 0 (this device) | K991784 | Renew Lead Extension | Advanced Neuromodulation Systems | 1999 | — |
| +1 | K992946 | Renew Receiver | Advanced Neuromodulation Systems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K960728 | One Step Connect Leads (Quattrode, Octrode, Cervitrode)Summary page 2…ame: Implanted Spinal Cord Stimulator for Pain Relief Predicate Device: Advanced Neuromodulation Systems, Inc., currently markets One Step Connect™ Leads under 510(k) # K960728 and Octrode Neurostim Receiver under 510(k) # K930536. Device Description: The Renew Lead Extension consists of a silicone conne… | 1996 |
| * | K930536 | Neuromed Octrode Model MNR-88A-B-C Neurostim RecSummary page 2…Predicate Device: Advanced Neuromodulation Systems, Inc., currently markets One Step Connect™ Leads under 510(k) # K960728 and Octrode Neurostim Receiver under 510(k) # K930536. Device Description: The Renew Lead Extension consists of a silicone connector body, with Platinum/Iridium contacts, and braided… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992946 | Renew Receiver | 1999 | 0 |
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 4 ancestors has a recall.
- Of its descendants, K992946 (Advanced Neuromodulation Systems, 1999) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K960728.
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.
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?
ANS Lead Extensions 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. Lead extensions are intended to be used with Advanced Neuromodulation Systems’, leads, receivers, transmitters, and antennae.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991784 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991784: Renew Lead Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991784
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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