510(k) · Cleared
ClearedArthrex Knotless Mini TightRopes
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 Dec 17, 2021 as substantially equivalent to K133275 (Arthrex, Inc., 2014) and 2 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1979. 1 later device descends from it.
- Decided
- Dec 17, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K792022 (1979). 57 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 2 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 1 generation backK133275 Mini TightropeArthrex, Inc. · 2014
- This deviceK213644 Arthrex Knotless Mini TightRopesArthrex, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240947 TENSOR® Suture Button SystemGlobus Medical, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 4 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 3 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 2 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 1 generation backK133275 Mini TightropeArthrex, Inc. · 2014
- This deviceK213644 Arthrex Knotless Mini TightRopesArthrex, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K240947TENSOR® Suture Button SystemGlobus Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −4 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −3 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| −2 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| −1 | K133275 | Mini Tightrope | Arthrex, Inc. | 2014 | — |
| 0 (this device) | K213644 | Arthrex Knotless Mini TightRopes | Arthrex, Inc. | 2021 | — |
| +1 | K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | 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 |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K133275 | Mini TightropeSummary page 4…888.3030: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class II Primary Predicate Device K133275: Arthrex Mini TightRopes Predicate Devices K061925: Arthrex Mini TightRope Repair Kit K090107… | 2014 |
| * | K061925 | Mini Tightrope Repair Kit, Model AR-8911DSSummary page 4…appliances and accessories Regulatory Class II Primary Predicate Device K133275: Arthrex Mini TightRopes Predicate Devices K061925: Arthrex Mini TightRope Repair Kit K090107: Arthrex Mini TightRope Reference Devices K122374:… | 2006 |
| * | K090107 | Mini TightropeSummary page 4…II Primary Predicate Device K133275: Arthrex Mini TightRopes Predicate Devices K061925: Arthrex Mini TightRope Repair Kit K090107: Arthrex Mini TightRope Reference Devices K122374: Arthrex Suture (UHMWPE) K181513: Arthrex P… | 2009 |
| † | K122374 | Arthrex Suture (Uhmwpe) | 2012 |
| † | K181513 | Arthrex PushLock Tenodesis Anchor | 2018 |
| † | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | 2020 |
| † | K212146 | Arthrex LoopLoc Knotless Suture | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240947 | TENSOR® Suture Button System | 2024 | 0 |
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 42 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 57 ancestors have a recall of any class.
- Of its descendants, K240947 (Globus Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K133275.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Knotless Mini TightRopes are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct to external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Knotless Mini TightRopes are intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as…
Read the full statement (236 words)
The Arthrex Knotless Mini TightRopes are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct to external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Knotless Mini TightRopes are 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 1st metatarsal -2nd metatarsal intermetatarsal angle.
The Arthrex Knotless Mini TightRopes, 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 Knotless Mini TightRopes are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process 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. The Arthrex Knotless Mini TightRopes are also indicated for use as adjuncts in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at 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/K213644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213644: Arthrex Knotless Mini TightRopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213644
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