510(k) · Cleared
ClearedArthrex ACL TightRope®, PCL TightRope®, and TightRope® II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Oct 5, 2022 as substantially equivalent to K202581 (Arthrex, Inc., 2020) and 2 other predicates after a 170-day review. Its family tree reaches back 9 generations to 1990. 6 later devices descend from it.
- Decided
- Oct 5, 2022
- Review
- 170 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K904436 (1990). 50 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations between
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK202581 Arthrex TightRope IIArthrex, Inc. · 2020
- This deviceK221128 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 · 3 generations on · 0 of its ownK260405 FiberTape ButtonArthrex, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK250867 Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK250424 Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 8 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 7 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 6 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 5 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 4 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK202581 Arthrex TightRope IIArthrex, Inc. · 2020
- This deviceK221128 Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231857Arthrex TightRope IIArthrex, Inc. · 2023 · cites it directly4descendants
- K241235Arthrex TightRope IIArthrex, Inc. · 2024 · 2 generations on3descendants
- K260405FiberTape ButtonArthrex, Inc. · 2026 · 3 generations on0descendants
- K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025 · 3 generations on0descendants
- K250424Arthrex TightRope Soft Button, RTArthrex, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −8 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −7 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −6 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −5 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −4 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −3 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −2 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −1 | K202581 | Arthrex TightRope II | Arthrex, Inc. | 2020 | — |
| 0 (this device) | 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 | — |
| +3 | K260405 | FiberTape Button | Arthrex, Inc. | 2026 | — |
| +3 | K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025 | — |
| +3 | K250424 | Arthrex TightRope Soft Button, RT | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K202581 | Arthrex TightRope IISummary page 4…21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class II Predicate Device K202581: Arthrex TightRope II K112990: ACL TightRope K110123: PCL TightRope Reference Device… | 2020 |
| * | K112990 | Acl Tightrope,Acl Tightrope Duuble BundleSummary page 4…etallic bone fixation appliances and accessories Regulatory Class II Predicate Device K202581: Arthrex TightRope II K112990: ACL TightRope K110123: PCL TightRope Reference Device K130217: Orthopediatrics ACL Reconstructive Sys… | 2011 |
| * | K110123 | PCL TightropeSummary page 4…and accessories Regulatory Class II Predicate Device K202581: Arthrex TightRope II K112990: ACL TightRope K110123: PCL TightRope Reference Device K130217: Orthopediatrics ACL Reconstructive System K201522: Arthrex Sy… | 2011 |
| † | K130217 | Orthopediatrics Acl Reconstructive System | 2013 |
| † | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | 2020 |
What descends from it? (6)
2 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 32 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 50 ancestors have a recall of any class.
- Of its descendants, K231857 (Arthrex, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K202581.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Arthrex ACL TightRope®, PCL TightRope®, and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221128: Arthrex ACL TightRope®, PCL TightRope®, and 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/K221128
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