510(k) Report

510(k) · Cleared

Recalled · 2010

Swift-Lock Anchor, Model 1192

K092371510(k) TraditionalCleared Dec 23, 2009140-day reviewClass II21 CFR 882.5880Recalls 1

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 Dec 23, 2009 after a 140-day review. The FDA summary names no predicate by number. 8 later devices descend from it. It has been recalled once.

Decided
Dec 23, 2009
Review
140 days
Class
Class II
Product code
GZB
Recalls
1
Predicates
0

8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2014: 1 descendant cleared2012: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared20052010201520202025
  1. This deviceK092371 Swift-Lock Anchor, Model 1192Advanced Neuromodulation Systems · 2009
  2. Descendant · cites it directly · 6 of its ownK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  3. Descendant · 2 generations on · 5 of its ownK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  4. Descendant · 2 generations on · 4 of its ownK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  5. Descendant · 2 generations on · 3 of its ownK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
  6. Descendant · 3 generations on · 2 of its ownK150924 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture…Anchor Innovation Medical (A.I.M.) · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011: 32012: 12014: 12015: 12017: 12019: 1
2011high 3 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all
  • K111462Fixate Tissue BandAnulex Technologies, Inc. · 2011 · cites it directly6descendants
  • K112849Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 2 generations on5descendants
  • K113400Fixate Tissue BandAnulex Technologies, Inc. · 2011 · 2 generations on4descendants
  • K113805Fixate Tissue BandAnulex Technologies, Inc. · 2012 · 2 generations on3descendants
  • K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M.…Anchor Innovation Medical (A.I.M.) · 2015 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092371Swift-Lock Anchor, Model 1192Advanced Neuromodulation Systems2009—
+1K111462Fixate Tissue BandAnulex Technologies, Inc.2011—
+2K112849Fixate Tissue BandAnulex Technologies, Inc.2011—
+2K113400Fixate Tissue BandAnulex Technologies, Inc.2011—
+2K113805Fixate Tissue BandAnulex Technologies, Inc.2012—
+3K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter…Anchor Innovation Medical (A.I.M.)2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201130
201210
201410
201510
201710
201910
FIG. 1 — Lineage of K092371, 2009–2019Source: 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K111462Fixate Tissue BandAnulex Technologies, Inc.20116
K140272Swift-Lock AnchorSt Jude Medical20140

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 22, 2010Not classifiedZ-1425-2010OtherDirections For Use of product incorrectly stated lead compatibility information.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K111462 (Anulex Technologies, Inc., 2011) has gone furthest, with 6 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. 2009, this device’s year, is highlighted.

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?

ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management 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 Swift-LockTM anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

Indications for use as stated in the FDA summary.

More from Advanced Neuromodulation Systems

25 FDA decisions under this applicant name. See the company

  • 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
  • K063080Tripole 8C and 16C and Exclaim 8 Lamitrode Series LeadsAdvanced Neuromodulation Systems · 2006

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/K092371 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092371: Swift-Lock Anchor, Model 1192.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092371

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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