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 Nov 4, 2020 as substantially equivalent to K112990 (Arthrex, Inc., 2011) after a 57-day review. Its family tree reaches back 8 generations to 1990. 9 later devices descend from it.
- Decided
- Nov 4, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904436 (1990). 28 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 6 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 5 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 4 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 3 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 2 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 1 generation backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- This deviceK202581 Arthrex TightRope IIArthrex, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK221128 Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK231857 Arthrex TightRope IIArthrex, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253693 Strut Suture; No-Tie ButtonRiverpoint Medical, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK260405 FiberTape ButtonArthrex, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc. · 2022 · cites it directly6descendants
- K231857Arthrex TightRope IIArthrex, Inc. · 2023 · cites it directly4descendants
- K241235Arthrex TightRope IIArthrex, Inc. · 2024 · 2 generations on3descendants
- K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC · 2026 · cites it directly0descendants
- K260405FiberTape ButtonArthrex, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −7 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −6 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −5 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −4 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −3 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −2 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −1 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K202581 | Arthrex TightRope II | Arthrex, Inc. | 2020 | — |
| +1 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Arthrex, Inc. | 2022 | — |
| +1 | K231857 | Arthrex TightRope II | Arthrex, Inc. | 2023 | — |
| +2 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
| +1 | K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | 2026 | — |
| +3 | K260405 | FiberTape Button | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (1)
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 4…appliances and accessories Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K112990: ACL TightRope and ACL TightRope Double Bundle Purpose of Submission This Traditional 510(k) premarket notification is submitte… | 2011 |
What descends from it? (9)
4 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 4 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K221128 (Arthrex, Inc., 2022) has gone furthest, with 6 descendants of its own.
- 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. 2020, 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 is intended to be used for fixation of bone to bone or soft tissue to bone, and is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202581: 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/K202581
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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