510(k) · Cleared
ClearedAcl Tightrope,Acl Tightrope Duuble Bundle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTY Pin, Fixation, Smooth
Cleared on Dec 19, 2011 as substantially equivalent to K100652 (Arthrex, Inc., 2010) after a 74-day review. Its family tree reaches back 7 generations to 1990. 49 later devices descend from it.
- Decided
- Dec 19, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K904436 (1990). 27 ancestors in all. 49 later devices descend from it, 10 citing it directly.
- Root · 7 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 6 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 5 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 4 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 3 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 2 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 1 generation backK100652 Acl TightropeArthrex, Inc. · 2010
- This deviceK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- Descendant · cites it directly · 35 of its ownK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- Descendant · cites it directly · 9 of its ownK202581 Arthrex TightRope IIArthrex, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK221128 Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK231857 Arthrex TightRope IIArthrex, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK241235 Arthrex TightRope IIArthrex, Inc. · 2024
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp · 2013 · cites it directly35descendants
- K202581Arthrex TightRope IIArthrex, Inc. · 2020 · cites it directly9descendants
- K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc. · 2022 · cites it directly6descendants
- K231857Arthrex TightRope IIArthrex, Inc. · 2023 · 2 generations on4descendants
- K241235Arthrex TightRope IIArthrex, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −6 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −5 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −4 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −3 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −2 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −1 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| 0 (this device) | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| +1 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| +1 | K202581 | Arthrex TightRope II | Arthrex, Inc. | 2020 | — |
| +1 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Arthrex, Inc. | 2022 | — |
| +2 | K231857 | Arthrex TightRope II | Arthrex, Inc. | 2023 | — |
| +3 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100652 | Acl Tightrope | 2010 |
| Kept off the family tree | K101837 | FDA’s K101837 is Acl Tightrope Double Bundle Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| Kept off the family tree | K101123 | FDA’s K101123 is Nexfin Model 2 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
What descends from it? (49)
See all 4910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB… | 2013 | 35 |
| K202581 | Arthrex TightRope II | 2020 | 9 |
| K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | 2022 | 6 |
| K203259 | FairFix Adjustable Button System | 2021 | 3 |
| K151004 | PULLUP® Adjustable Juxtacortical Fixation Device | 2015 | 2 |
| K191319 | Dunamis Fixation Button System | 2019 | 1 |
| K150416 | ProCinch Adjustable Loop Device | 2015 | 1 |
| K250424 | Arthrex TightRope Soft Button, RT | 2025 | 0 |
| K232941 | Megaloop Button System | 2024 | 0 |
| K220906 | Secure-Lock | 2022 | 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 21 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K130033 (Biomet Manufacturing Corp, 2013) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K100652.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ACL TightRope and ACL TightRope Double Bundle are 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112990: Acl Tightrope,Acl Tightrope Duuble Bundle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112990
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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