510(k) · Cleared
ClearedMini Tightrope
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 6, 2009 as substantially equivalent to K061925 (Arthrex, Inc., 2006) and 2 other predicates after a 203-day review. Its family tree reaches back 9 generations to 1979. 21 later devices descend from it.
- Decided
- Aug 6, 2009
- Review
- 203 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K792022 (1979). 55 ancestors in all. 21 later devices descend from it, 7 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 1 generation backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- This deviceK090107 Mini TightropeArthrex, Inc. · 2009
- Descendant · cites it directly · 11 of its ownK133275 Mini TightropeArthrex, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK140328 CMC Mini TightropeArthrex, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK133835 Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK111032 CMC Cable FixInstratek, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK241995 HyperFlex™ Bunion Correction SystemFootbridge Medical · 2024
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 1 generation backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- This deviceK090107 Mini TightropeArthrex, Inc. · 2009
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K133275Mini TightropeArthrex, Inc. · 2014 · cites it directly11descendants
- K140328CMC Mini TightropeArthrex, Inc. · 2014 · 2 generations on6descendants
- K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc. · 2014 · cites it directly2descendants
- K111032CMC Cable FixInstratek, Inc. · 2011 · cites it directly2descendants
- K241995HyperFlex™ Bunion Correction SystemFootbridge Medical · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −1 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| +1 | K133275 | Mini Tightrope | Arthrex, Inc. | 2014 | — |
| +2 | K140328 | CMC Mini Tightrope | Arthrex, Inc. | 2014 | — |
| +1 | K133835 | Arthrosurface Kissloc Knotless Suture System | Arthrosurface, Inc. | 2014 | — |
| +1 | K111032 | CMC Cable Fix | Instratek, Inc. | 2011 | — |
| +1 | K241995 | HyperFlex™ Bunion Correction System | Footbridge Medical | 2024 | — |
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 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 16.4 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061925 | Mini Tightrope Repair Kit, Model AR-8911DSSummary page 1…ct Code - HTN - Single/multiple component metallic bone fixation appliances Classification and accessories Name Predicate Device Mini TightRope Repair Kit, K061925 Mini TightRope FT Repair Kit, K071978 ACL RetroConstruction Button Kit, K031666 Dev… | 2006 |
| * | K071978 | Mini Tightrope FT Repair KitSummary page 1…fixation appliances Classification and accessories Name Predicate Device Mini TightRope Repair Kit, K061925 Mini TightRope FT Repair Kit, K071978 ACL RetroConstruction Button Kit, K031666 Device The Mini TightRope is designed as either two metal b… | 2007 |
| * | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSSummary page 1…Name Predicate Device Mini TightRope Repair Kit, K061925 Mini TightRope FT Repair Kit, K071978 ACL RetroConstruction Button Kit, K031666 Device The Mini TightRope is designed as either two metal buttons with a Description and pre-threaded FiberWire suture… | 2003 |
What descends from it? (21)
See all 217 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 30 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 55 ancestors have a recall of any class.
- Of its descendants, K133275 (Arthrex, Inc., 2014) has gone furthest, with 11 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. 2009, 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 Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following: 1)…
Read the full statement (211 words)
The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:
1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
2) Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1 st metatarsal -2nd metatarsal intermetatarsal angle.
The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090107: Mini Tightrope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090107
Report an extraction error
Are you the manufacturer?
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