510(k) · Cleared
ClearedTACTIX Vector Syndesmosis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, LLC · HTN Washer, Bolt Nut
Cleared on Aug 1, 2024 as substantially equivalent to K201522 (Arthrex, Inc., 2020) and 1 other predicate after a 210-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Aug 1, 2024
- Review
- 210 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K904436 (1990). 63 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 6 generations between
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK173278 ToggleLoc SystemBiomet, Inc. · 2018
- This deviceK240035 TACTIX Vector Syndesmosis SystemVilex, LLC · 2024
- Descendant · cites it directly · 0 of its ownK243408 TACTIX Vector Syndesmosis SystemVilex, LLC · 2024
Show all 10 generations
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 9 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 8 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 7 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 6 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 5 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 4 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- 1 generation backK173278 ToggleLoc SystemBiomet, Inc. · 2018
- This deviceK240035 TACTIX Vector Syndesmosis SystemVilex, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K243408TACTIX Vector Syndesmosis SystemVilex, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −9 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −8 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −7 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −6 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −5 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −4 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −3 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −2 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| −1 | K173278 | ToggleLoc System | Biomet, Inc. | 2018 | — |
| 0 (this device) | K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024 | — |
| +1 | K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.5 · 6 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 |
|---|---|---|---|
| * | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemSummary page 4…ber 888.3030 Product Code HTN I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201522 Arthrex Syndesmosis TightRope XP Buttress Plate Implant Systg| | HTN K173278 ToggleLoc System (Only ToggleLoc with ZipTight Fixat… | 2020 |
| * | K173278 | ToggleLoc SystemSummary page 4…7.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201522 Arthrex Syndesmosis TightRope XP Buttress Plate Implant Systg| | HTN K173278 ToggleLoc System (Only ToggleLoc with ZipTight Fixation Devigg| | MBI K230204 Alphalok Plating System (reference device) HRS Devi… | 2018 |
| † | K230204 | ALPHALOK Plating System | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243408 | TACTIX Vector Syndesmosis System | 2024 | 0 |
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 34 years and passes through 7 companies; a new generation was cleared every 3.7 years on median.
- 10 of the 63 ancestors have a recall of any class.
- Of its descendants, K243408 (Vilex, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K201522.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the TACTIC Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
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/K240035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240035: TACTIX Vector Syndesmosis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240035
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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