510(k) · Cleared
ClearedFixate Tissue Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anulex Technologies, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Oct 27, 2011 as substantially equivalent to K111462 (Anulex Technologies, Inc., 2011) after a 28-day review. Its family tree reaches back 6 generations to 1994. 5 later devices descend from it.
- Decided
- Oct 27, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930738 (1994). 10 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 5 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
- 4 generations backK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
- 3 generations backK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
- 2 generations backK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
- 1 generation backK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- This deviceK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
- Descendant · 2 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
- Descendant · 2 generations on · 1 of its ownK172644 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod…Stimwave Technologies Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK191466 SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K113400Fixate Tissue BandAnulex Technologies, Inc. · 2011 · cites it directly4descendants
- K113805Fixate Tissue BandAnulex Technologies, Inc. · 2012 · cites it directly3descendants
- 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 · 2 generations on2descendants
- K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…Stimwave Technologies Incorporated · 2017 · 2 generations on1descendant
- K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −5 | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corp. | 2002 | 7 |
| −4 | K061386 | Anchor Band Suturing System, Model SR-AB | Anulex Technologies, Inc. | 2006 | — |
| −3 | K062307 | Xclose Tissue Repair System, Model SRS | Anulex Technologies, Inc. | 2006 | — |
| −2 | K091432 | Xclose Tissue Repair System, Model XC-200-01 | Anulex Technologies, Inc. | 2009 | — |
| −1 | K111462 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| 0 (this device) | K112849 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| +1 | K113400 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| +1 | K113805 | Fixate Tissue Band | Anulex Technologies, Inc. | 2012 | — |
| +2 | K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter… | Anchor Innovation Medical (A.I.M.) | 2015 | — |
| +2 | K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with… | Stimwave Technologies Incorporated | 2017 | — |
| +3 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K111462 | Fixate Tissue Band | 2011 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K113400 (Anulex Technologies, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K111462.
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. 2011, 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 fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.
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/K112849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112849: Fixate Tissue Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112849
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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