510(k) · Cleared
ClearedMini Tightrope FT Repair Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTN Washer, Bolt Nut
Cleared on Aug 15, 2007 as substantially equivalent to K061925 (Arthrex, Inc., 2006) after a 28-day review. Its family tree reaches back 8 generations to 1979. 22 later devices descend from it.
- Decided
- Aug 15, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K792022 (1979). 42 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 6 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 5 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 4 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 3 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 2 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 1 generation backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- This deviceK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- Descendant · cites it directly · 21 of its ownK090107 Mini TightropeArthrex, Inc. · 2009
- Descendant · 2 generations on · 11 of its ownK133275 Mini TightropeArthrex, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK140328 CMC Mini TightropeArthrex, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK133835 Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK111032 CMC Cable FixInstratek, Inc. · 2011
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K090107Mini TightropeArthrex, Inc. · 2009 · cites it directly21descendants
- K133275Mini TightropeArthrex, Inc. · 2014 · 2 generations on11descendants
- K140328CMC Mini TightropeArthrex, Inc. · 2014 · 3 generations on6descendants
- K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc. · 2014 · 2 generations on2descendants
- K111032CMC Cable FixInstratek, Inc. · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −7 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −6 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −5 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −4 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −3 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −2 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −1 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| +1 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| +2 | K133275 | Mini Tightrope | Arthrex, Inc. | 2014 | — |
| +3 | K140328 | CMC Mini Tightrope | Arthrex, Inc. | 2014 | — |
| +2 | K133835 | Arthrosurface Kissloc Knotless Suture System | Arthrosurface, Inc. | 2014 | — |
| +2 | K111032 | CMC Cable Fix | Instratek, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 16.5 · 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? (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 |
|---|---|---|---|
| * | K061925 | Mini Tightrope Repair Kit, Model AR-8911DSSummary page 1…ne Name fixation appliances and accessories PredicateDevice Arthrex Mini TightRope Repair Kit, K061925 Device DescriptionandIntended The Mini TightRopeTM FT Repair Kit is designed… | 2006 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090107 | Mini Tightrope | 2009 | 21 |
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 28 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K090107 (Arthrex, Inc., 2009) has gone furthest, with 21 descendants of its own.
- 10 other devices also cite its predicate K061925.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Mini TightRope FP Repair Kit is intended as an adjunct in firactuIre repair involving metaphyseal and periarticular small bone fragrnents 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 Mini TightRope FT Repair Kit is intended 1o provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation…
Read the full statement (113 words)
The Mini TightRope FP Repair Kit is intended as an adjunct in firactuIre repair involving metaphyseal and periarticular small bone fragrnents 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 Mini TightRope FT Repair Kit is intended 1o provide fixation during the healing process following:
1) Syndesmotic trauma, such as fixation of dorsad distal radioul nar ligament (DRUL) disruptions;
2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
3) Hadlux Valgus reconstruction (conrection) by providing for tie reduction of It metatarsal -2I' metatarsal inteimetatarsal angle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071978 · printed Nov 3, 2026
Cite this page
510(k) Report. “K071978: Mini Tightrope FT Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K071978
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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