510(k) · Cleared
ClearedMini Tightrope Repair Kit, Model AR-8911DS
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 Oct 31, 2006 as substantially equivalent to K041189 (Arthrex, Inc., 2004) and 2 other predicates after a 116-day review. Its family tree reaches back 7 generations to 1979. 33 later devices descend from it.
- Decided
- Oct 31, 2006
- Review
- 116 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K792022 (1979). 41 ancestors in all. 33 later devices descend from it, 11 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 backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- This deviceK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- Descendant · cites it directly · 22 of its ownK071978 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 · cites it directly · 5 of its ownK141420 FastforwardMedShape, Inc. · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K071978Mini Tightrope FT Repair KitArthrex, Inc. · 2007 · cites it directly22descendants
- K090107Mini TightropeArthrex, Inc. · 2009 · cites it directly21descendants
- K133275Mini TightropeArthrex, Inc. · 2014 · 2 generations on11descendants
- K140328CMC Mini TightropeArthrex, Inc. · 2014 · 3 generations on6descendants
- K141420FastforwardMedShape, Inc. · 2014 · cites it directly5descendants
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 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| +1 | 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 | — |
| +1 | K141420 | Fastforward | MedShape, Inc. | 2014 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K041189 | Arthrex Trimit FamilySummary page 1…metallic bone fixation appliances and accessories: 21 CFR 888.3030 PREDICATE DEVICES K041189: TRIM-IT Family (Arthrex, Inc.) K052776: TightRope AC Device (Arthr!.x, Inc.) K043248: TightRope Syndesmosis De!ice (Arthrex, Inc… | 2004 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 1…accessories: 21 CFR 888.3030 PREDICATE DEVICES K041189: TRIM-IT Family (Arthrex, Inc.) K052776: TightRope AC Device (Arthr!.x, Inc.) K043248: TightRope Syndesmosis De!ice (Arthrex, Inc.) DEVICE DESCRIPTION AND INTENDED USE… | 2005 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 1…sories: 21 CFR 888.3030 PREDICATE DEVICES K041189: TRIM-IT Family (Arthrex, Inc.) K052776: TightRope AC Device (Arthr!.x, Inc.) K043248: TightRope Syndesmosis De!ice (Arthrex, Inc.) DEVICE DESCRIPTION AND INTENDED USE The Mini TightRope T M Repair Kit is desiigned… | 2005 |
What descends from it? (33)
See all 3311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071978 | Mini Tightrope FT Repair Kit | 2007 | 22 |
| K090107 | Mini Tightrope | 2009 | 21 |
| K141420 | Fastforward | 2014 | 5 |
| K082384 | Hav-Lok Bunion Correction System | 2008 | 5 |
| K091763 | Michelangelo Bunion System - Mabs, Model: MA6000 | 2009 | 4 |
| K133835 | Arthrosurface Kissloc Knotless Suture System | 2014 | 2 |
| K213644 | Arthrex Knotless Mini TightRopes | 2021 | 1 |
| K200332 | EXPERT - Joint Fixation System | 2020 | 1 |
| K170440 | KISSloc Suture System | 2017 | 1 |
| K143092 | Tensyn Plug | 2015 | 1 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K071978 (Arthrex, Inc., 2007) has gone furthest, with 22 descendants of its own.
- 3 other devices also cite its predicate K041189.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TightRopeTM Repair Kit 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 Arthrex Mini TightRopeT M Repair Kit is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as…
Read the full statement (114 words)
The Mini TightRopeTM Repair Kit 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 Arthrex Mini TightRopeT M Repair Kit is intended to provide fixation during the healing process following:
1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
2) Tarasometatarsal (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 l1t metatarsal - 2 nd metatarsal intermetatarsal angle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061925 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061925: Mini Tightrope Repair Kit, Model AR-8911DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061925
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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