510(k) Report

510(k) · Cleared

Cleared

Fixate Tissue Band

K111462510(k) TraditionalCleared Sep 8, 2011105-day reviewClass II21 CFR 882.5880

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Anulex Technologies, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Cleared on Sep 8, 2011 as substantially equivalent to K100572 (Anulex Technologies, Inc., 2010) and 2 other predicates after a 105-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.

Decided
Sep 8, 2011
Review
105 days
Class
Class II
Product code
GZB
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K930738 (1994). 9 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2004: 1 other ancestor1998: 1 other ancestor2012: 1 descendant cleared2011: 2 descendants cleared2017: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant clearedK930738 · Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc · Deknatel, Inc. · 1994 · recalledK021019 · Cottony II, Silky II Polydek & Tevdek II Polyester Suture · Genzyme Corp. · 2002 · recalled×2: 2 generations cleared close together, K061386 (2006), K062307 (2006) K091432 · Xclose Tissue Repair System, Model XC-200-01 · Anulex Technologies, Inc. · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K091432 · Xclose Tissue Repair System, Model XC-200-01 · Anulex Technologies, Inc. · 2009K062307 · Xclose Tissue Repair System, Model SRS · Anulex Technologies, Inc. · 2006K061386 · Anchor Band Suturing System, Model SR-AB · Anulex Technologies, Inc. · 2006K021019 · Cottony II, Silky II Polydek & Tevdek II Polyester Suture · Genzyme Corp. · 2002 · recalledK930738 · Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc · Deknatel, Inc. · 1994 · recalled−50
  1. Root · 5 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
  2. 4 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
  3. 3 generations backK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
  4. 2 generations backK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
  5. 1 generation backK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
  6. This deviceK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  7. Descendant · cites it directly · 5 of its ownK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  8. Descendant · cites it directly · 4 of its ownK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
  9. Descendant · cites it directly · 3 of its ownK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
  10. 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
  11. Descendant · 2 generations on · 1 of its ownK172644 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod…Stimwave Technologies Incorporated · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12015: 12017: 12019: 1
2011high 2 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K112849Fixate Tissue BandAnulex Technologies, Inc. · 2011 · cites it directly5descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K930738Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc.19949
−4K021019Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp.20027
−3K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc.2006—
−2K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc.2006—
−1K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc.2009—
0 (this device)K111462Fixate Tissue BandAnulex Technologies, Inc.2011—
+1K112849Fixate Tissue BandAnulex Technologies, Inc.2011—
+1K113400Fixate Tissue BandAnulex Technologies, Inc.2011—
+1K113805Fixate Tissue BandAnulex Technologies, Inc.2012—
+2K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter…Anchor Innovation Medical (A.I.M.)2015—
+2K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with…Stimwave Technologies Incorporated2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201510
201710
201910
FIG. 1 — Lineage of K111462, 1994–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K100572Versaclose, Model VC-200-01
Summary page 1
…g predicate devices: * Anulex Technologies Versaclose (K100572 cleared March 17, 2010) * Anulex Technologies XcloseThf Tissue Repair System…
Anulex Technologies, Inc.2010—
*K091432Xclose Tissue Repair System, Model XC-200-01
Summary page 1
…(K100572 cleared March 17, 2010) * Anulex Technologies XcloseThf Tissue Repair System (K091432 cleared June 12, 2009) * Advanced Neuromodulation Systems Swift-Lock Anchor…
Anulex Technologies, Inc.2009—
*K092371Swift-Lock Anchor, Model 1192
Summary page 1
…(K091432 cleared June 12, 2009) * Advanced Neuromodulation Systems Swift-Lock Anchor (K092371 cleared December 23, 2009) Device Description: The fiXate Tissue Band consists of an adjustable loop of non-…
Advanced Neuromodulation Systems20091

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K112849Fixate Tissue BandAnulex Technologies, Inc.20115
K113400Fixate Tissue BandAnulex Technologies, Inc.20114
K113805Fixate Tissue BandAnulex Technologies, Inc.20123

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 9 ancestors have a recall of any class.
  • Of its descendants, K112849 (Anulex Technologies, Inc., 2011) has gone furthest, with 5 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. 2011, 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?

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 as stated in the FDA summary.

More from Anulex Technologies, Inc.

12 FDA decisions under this applicant name. See the company

  • K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc. · 2012
  • K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc. · 2012
  • K113805Fixate Tissue BandAnulex Technologies, Inc. · 2012
  • K113400Fixate Tissue BandAnulex Technologies, Inc. · 2011
  • K112849Fixate Tissue BandAnulex Technologies, Inc. · 2011

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/K111462 · printed Nov 5, 2026

Cite this page

510(k) Report. “K111462: Fixate Tissue Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111462

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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