510(k) · Cleared
ClearedTensyn Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dallen Medical, Inc. · HTN Washer, Bolt Nut
Cleared on Nov 15, 2013 as substantially equivalent to K043248 (Arthrex, Inc., 2005) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1979. 5 later devices descend from it.
- Decided
- Nov 15, 2013
- Review
- 147 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K792022 (1979). 44 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 2 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 1 generation backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- This deviceK131850 Tensyn BandDallen Medical, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK133858 Tensyn BandDallen Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK141264 Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK143092 Tensyn PlugDallen Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK153211 M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK150359 Tensyn PlugDallen Medical, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K133858Tensyn BandDallen Medical, Inc. · 2014 · cites it directly3descendants
- K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc. · 2014 · 2 generations on2descendants
- K143092Tensyn PlugDallen Medical, Inc. · 2015 · cites it directly1descendant
- K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. · 2016 · cites it directly0descendants
- K150359Tensyn PlugDallen Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −6 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −5 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −2 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −1 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| 0 (this device) | K131850 | Tensyn Band | Dallen Medical, Inc. | 2013 | — |
| +1 | K133858 | Tensyn Band | Dallen Medical, Inc. | 2014 | — |
| +2 | K141264 | Tensyn Band, Tensyn Fracture Plates | Dallen Medical, Inc. | 2014 | — |
| +1 | K143092 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
| +1 | K153211 | M-Fix Acromioclavicular Device | Coracoid Solutions, Inc. | 2016 | — |
| +2 | K150359 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 16.4 · 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 |
|---|---|---|---|
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 1…lass If PREDICATE DEVICES: Tightrope Syndesmosis Repair Kit, Titanium, Model Ar-8920D3s; Stainless Steel. Model Ar-8921 Ds (K043248) ToggleLoc System (K083070) Product Description:… | 2005 |
| * | K083070 | Toggleloc SystemSummary page 1…sis Repair Kit, Titanium, Model Ar-8920D3s; Stainless Steel. Model Ar-8921 Ds (K043248) ToggleLoc System (K083070) Product Description: h The Tensyn… | 2008 |
What descends from it? (5)
3 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 34 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 44 ancestors have a recall of any class.
- Of its descendants, K133858 (Dallen Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 25 other devices also cite its predicate K043248.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Tensynrm Band is intended to provide fixation during the healing process following an isolated syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131850: Tensyn Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131850
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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