510(k) · Cleared
ClearedGrip Lock Anchor, Model 411374
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurological · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Dec 11, 2001 as substantially equivalent to K972906 (Medtronic Vascular, 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 11, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P970004 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backP970004 Medtronic Interstim Therapy System for Urinary ControlMedtronic Neuromodulation · 1997 · Recalled
- This deviceK013063 Grip Lock Anchor, Model 411374Medtronic Neurological · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P970004 | Medtronic Interstim Therapy System for Urinary Control | Medtronic Neuromodulation | 1997 | 5 |
| 0 (this device) | K013063 | Grip Lock Anchor, Model 411374 | Medtronic Neurological | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K972906 | Medtronic Twist Lock Anchor (Partnumber 103953/3550TLA)Summary page 2…Manager DEVICE NAME Grip-lockTM Anchor NAME OF PREDICATE OR LEGALLY MARKETED DEVICE Medtronic Twist-Lock Anchor (Part number 103963, or Model 3550TLA (kit) / 510(k): K972906), deemed substantially equivalent on February 6, 1998. DESCRIPTION OF DEVICE The Grip-lockTM Anchor is an implantable, sterile,… | 1998 |
| * | P970004 | Medtronic Interstim Therapy System for Urinary ControlSummary page 3…d substantially equivalent on February 6, 1998. e Medtronic silicone anchors currently packaged in the lead kits approved for use with sacral nerve stimulation systems (P970004, approved September 29, 1997). These Medtronic anchors are devices which are currently in commercial distribution. The Twist-Loc… | 1997 |
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?
- 1 of the 2 ancestors has a recall of any class.
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?
The Medtronic Grip-lockm Anchor is indicated for use to facilitate Medtronic neurological lead fixation.
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/K013063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013063: Grip Lock Anchor, Model 411374.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013063
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026