510(k) · Cleared
ClearedPCL Tightrope
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 Apr 28, 2011 as substantially equivalent to K071176 (Arthrex, Inc., 2007) after a 100-day review. Its family tree reaches back 7 generations to 1997. 8 later devices descend from it.
- Decided
- Apr 28, 2011
- Review
- 100 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971358 (1997). 20 ancestors in all, the oldest K915424 (1993). 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 3 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 2 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 1 generation backK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- This deviceK110123 PCL TightropeArthrex, Inc. · 2011
- 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
- Descendant · 4 generations on · 0 of its ownK260405 FiberTape ButtonArthrex, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK250867 Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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
- K260405FiberTape ButtonArthrex, Inc. · 2026 · 4 generations on0descendants
- K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −6 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −3 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −2 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −1 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K110123 | PCL Tightrope | Arthrex, Inc. | 2011 | — |
| +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 | — |
| +4 | K260405 | FiberTape Button | Arthrex, Inc. | 2026 | — |
| +4 | K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 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 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071176 | Modification to: Arthrex Interference ScrewSummary page 1…1 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture. Predicate Device K071 176: Arthrex BioComposite Interference Screw KJ 006S2: Arthrex ACL TigbtRope… | 2007 |
| Kept off the family tree | K100652 | FDA’s K100652 is Acl Tightrope 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? (8)
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 14 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K221128 (Arthrex, Inc., 2022) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K071176.
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 Arthrex PCL TightRope 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. For example, ACL/PCL repair and reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110123: PCL Tightrope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110123
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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