510(k) · Cleared
ClearedA.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anchor Innovation Medical (A.I.M.) · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Jul 27, 2015 as substantially equivalent to K113805 (Anulex Technologies, Inc., 2012) after a 112-day review. Its family tree reaches back 9 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 27, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930738 (1994). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 2 generations backK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 1 generation backK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
- This deviceK150924 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture…Anchor Innovation Medical (A.I.M.) · 2015
- Descendant · cites it directly · 1 of its ownK172644 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod…Stimwave Technologies Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK191466 SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 8 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
- 7 generations backK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
- 6 generations backK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
- 5 generations backK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
- 4 generations backK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 3 generations backK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 2 generations backK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 1 generation backK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
- This deviceK150924 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture…Anchor Innovation Medical (A.I.M.) · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −8 | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corp. | 2002 | 7 |
| −7 | K061386 | Anchor Band Suturing System, Model SR-AB | Anulex Technologies, Inc. | 2006 | — |
| −6 | K062307 | Xclose Tissue Repair System, Model SRS | Anulex Technologies, Inc. | 2006 | — |
| −5 | K091432 | Xclose Tissue Repair System, Model XC-200-01 | Anulex Technologies, Inc. | 2009 | — |
| −4 | K111462 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| −3 | K112849 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| −2 | K113400 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| −1 | K113805 | Fixate Tissue Band | Anulex Technologies, Inc. | 2012 | — |
| 0 (this device) | K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter… | Anchor Innovation Medical (A.I.M.) | 2015 | — |
| +1 | K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with… | Stimwave Technologies Incorporated | 2017 | — |
| +2 | K191466 | SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K113805 | Fixate Tissue BandSummary page 4…21 CFR 882.5880 Product Codes: GZB/GAT Device Class: Class II Predicate Devices: Boston Scientific Fixate Suturing Device (K113805) Premarket Notification: Traditional 510(k) Anchor Innovation Medical A.I.M. Lead Loop Sutu… | 2012 |
| † | K133770 | A.I.M. Knotless Meniscal Repair Device | 2014 |
| † | K132461 | A.I.M. Suture Anchor | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading… | 2017 | 1 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K172644 (Stimwave Technologies Incorporated, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K113805.
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. 2015, this device’s year, is highlighted.
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 A.I.M. Lead Loop Suturing Device is intended for use in securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150924: A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150924
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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