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 Feb 28, 2014 as substantially equivalent to K131850 (Dallen Medical, Inc., 2013) and 3 other predicates after a 71-day review. Its family tree reaches back 11 generations to 1976. 3 later devices descend from it.
- Decided
- Feb 28, 2014
- Review
- 71 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K761228 (1976). 123 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 7 generations between
- 3 generations backK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- 2 generations backK101484 Compressyn BandDallen Medical · 2011
- 1 generation backK130431 Compressyn BandDallen Medical, Inc. · 2013
- This deviceK133858 Tensyn BandDallen Medical, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK141264 Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK143092 Tensyn PlugDallen Medical, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK150359 Tensyn PlugDallen Medical, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 10 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 9 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 8 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 7 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 6 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 5 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 4 generations backK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
- 3 generations backK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- 2 generations backK101484 Compressyn BandDallen Medical · 2011
- 1 generation backK130431 Compressyn BandDallen Medical, Inc. · 2013
- This deviceK133858 Tensyn BandDallen Medical, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −10 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −9 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −8 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −7 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −6 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −5 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −4 | K051165 | KLS Martin Sternal Talon | KLS-Martin L.P. | 2006 | — |
| −3 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| −2 | K101484 | Compressyn Band | Dallen Medical | 2011 | — |
| −1 | K130431 | Compressyn Band | Dallen Medical, Inc. | 2013 | — |
| 0 (this device) | K133858 | Tensyn Band | Dallen Medical, Inc. | 2014 | — |
| +1 | K141264 | Tensyn Band, Tensyn Fracture Plates | Dallen Medical, Inc. | 2014 | — |
| +2 | K143092 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
| +3 | K150359 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 10 | 0 |
| 1995 | 6 | 0 |
| 1996 | 16 | 0 |
| 1997 | 8 | 0 |
| 1998 | 15 | 0 |
| 1999 | 10 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 2 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K131850 | Tensyn BandSummary page 1…/ Suture CLASSIFICATION NAME: Washer, Bolt Nut, CER 888.3030 (code HTN) DEVICE CLASSIFICATION: Class 11 PREDICATE DEVICES: Tenysn Band (K 131850) Tightrope Syndesmosis Repair Kit, Titanium, Model Ar-8920Ds; Stain… | 2013 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 1…(K 131850) Tightrope Syndesmosis Repair Kit, Titanium, Model Ar-8920Ds; Stainless Steel. Model Ar-8921 Ds (K043248) ToggleL-oc System (K083070) Compressyn Band (K130431) Product De… | 2005 |
| * | K083070 | Toggleloc SystemSummary page 1…mosis Repair Kit, Titanium, Model Ar-8920Ds; Stainless Steel. Model Ar-8921 Ds (K043248) ToggleL-oc System (K083070) Compressyn Band (K130431) Product Description: The Tensyn Tm Band is a knotless system for fixa… | 2008 |
| * | K130431 | Compressyn BandSummary page 1…Ar-8920Ds; Stainless Steel. Model Ar-8921 Ds (K043248) ToggleL-oc System (K083070) Compressyn Band (K130431) Product Description: The Tensyn Tm Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn TmBand is a l… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141264 | Tensyn Band, Tensyn Fracture Plates | 2014 | 2 |
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 38 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 123 ancestors have a recall of any class.
- Of its descendants, K141264 (Dallen Medical, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K131850.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Tensyn™ Band 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 which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133858: 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/K133858
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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