510(k) · Cleared
ClearedArthrex TightRope Soft Button, RT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 11, 2025 as substantially equivalent to K112990 (Arthrex, Inc., 2011) and 1 other predicate after a 25-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Mar 11, 2025
- Review
- 25 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K961555 (1996). 122 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 12 generations between
- 3 generations backK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
- 2 generations backK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
- 1 generation backK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- This deviceK250424 Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025
Show all 16 generations
- Root · 16 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 15 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 14 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 13 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 12 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 11 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 10 generations backK112237 Microsuture AnchorsArthrex, Inc. · 2011
- 9 generations backK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
- 8 generations backK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
- 7 generations backK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
- 6 generations backK200341 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- 5 generations backK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- 4 generations backK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
- 3 generations backK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
- 2 generations backK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
- 1 generation backK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- This deviceK250424 Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −15 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −14 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −13 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −12 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −11 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −10 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| −9 | K140476 | Arthrex Fibertak Suture Anchor | Arthrex, Inc. | 2014 | — |
| −8 | K151230 | Arthrex FiberTak Anchors | Arthrex, Inc. | 2015 | — |
| −7 | K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2018 | — |
| −6 | K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| −5 | K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| −4 | K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
| −3 | K231330 | FiberTak® Suture Anchor | Arthrex, Inc. | 2023 | — |
| −2 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. | 2023 | — |
| −1 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
| 0 (this device) | K250424 | Arthrex TightRope Soft Button, RT | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K112990 | Acl Tightrope,Acl Tightrope Duuble BundleSummary page 5…Soft Tissue Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fastener Regulatory Class II Primary Predicate K112990 – Arthrex ACL TightRope RC Additional Predicate K241235 – Arthrex TightRope II RT Reference Devices K230976 – Arthrex Ra… | 2011 |
| * | K241235 | Arthrex TightRope IISummary page 5…or threaded metallic bone fastener Regulatory Class II Primary Predicate K112990 – Arthrex ACL TightRope RC Additional Predicate K241235 – Arthrex TightRope II RT Reference Devices K230976 – Arthrex Radiopaque FiberTape Cerclage sutures… | 2024 |
| † | K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 122 ancestors have a recall of any class.
- 9 other devices also cite its predicate K112990.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; 1TB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250424: Arthrex TightRope Soft Button, RT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250424
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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