510(k) · Cleared
ClearedArthrex TightRope II
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 Aug 8, 2023 as substantially equivalent to K130033 (Biomet Manufacturing Corp, 2013) and 2 other predicates after a 46-day review. Its family tree reaches back 10 generations to 1990. 4 later devices descend from it.
- Decided
- Aug 8, 2023
- Review
- 46 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K904436 (1990). 84 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 6 generations between
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK202581 Arthrex TightRope IIArthrex, Inc. · 2020
- 1 generation backK221128 Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc. · 2022
- This deviceK231857 Arthrex TightRope IIArthrex, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260405 FiberTape ButtonArthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250867 Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK250424 Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 9 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 8 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 7 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 6 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 5 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 4 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 3 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 2 generations backK202581 Arthrex TightRope IIArthrex, Inc. · 2020
- 1 generation backK221128 Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc. · 2022
- This deviceK231857 Arthrex TightRope IIArthrex, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K241235Arthrex TightRope IIArthrex, Inc. · 2024 · cites it directly3descendants
- K260405FiberTape ButtonArthrex, Inc. · 2026 · 2 generations on0descendants
- K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025 · 2 generations on0descendants
- K250424Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −9 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −8 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −7 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −6 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −5 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −4 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −3 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −2 | K202581 | Arthrex TightRope II | Arthrex, Inc. | 2020 | — |
| −1 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Arthrex, Inc. | 2022 | — |
| 0 (this device) | K231857 | Arthrex TightRope II | Arthrex, Inc. | 2023 | — |
| +1 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
| +2 | K260405 | FiberTape Button | Arthrex, Inc. | 2026 | — |
| +2 | K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025 | — |
| +2 | 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 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Summary page 4…threaded metallic bone fastener Regulatory Class II Primary Predicate Device K130033 Zimmer Biomet ToggleLoc™ Reference Devices K221128 Arthrex® TightRope II… | 2013 |
| * | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IISummary page 4…Regulatory Class II Primary Predicate Device K130033 Zimmer Biomet ToggleLoc™ Reference Devices K221128 Arthrex® TightRope II K202581 Arthrex® TightRope II Purpose of Sub… | 2022 |
| * | K202581 | Arthrex TightRope IISummary page 4…edicate Device K130033 Zimmer Biomet ToggleLoc™ Reference Devices K221128 Arthrex® TightRope II K202581 Arthrex® TightRope II Purpose of Submission This Traditional 510(k) premarket notification is… | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241235 | Arthrex TightRope II | 2024 | 3 |
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 33 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 11 of the 84 ancestors have a recall of any class.
- Of its descendants, K241235 (Arthrex, Inc., 2024) has gone furthest, with 3 descendants of its own.
- 16 other devices also cite its predicate K130033.
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. 2023, 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 II devices are 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 devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231857: Arthrex TightRope II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231857
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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