510(k) · Cleared
ClearedR3ACT Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 25, 2021 as substantially equivalent to K173550 (Akros Medical, 2017) and 3 other predicates after a 200-day review. Its family tree reaches back 9 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 25, 2021
- Review
- 200 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K904436 (1990). 66 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 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 backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK211770 R3ACT Stabilization SystemParagon 28, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK240594 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK253886 Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026
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 backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK211770 R3ACT Stabilization SystemParagon 28, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023 · cites it directly2descendants
- K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024 · 2 generations on1descendant
- K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026 · 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 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| 0 (this device) | K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021 | — |
| +1 | K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023 | — |
| +2 | K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2024 | — |
| +3 | K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026 | — |
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 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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? (4)
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 |
|---|---|---|---|
| * | K173550 | Akros FibuLink™ Syndesmosis Repair KitSummary page 5…be used in conjunction with the Baby Gorilla®/Gorilla® Plating System (K203511). Predicate Device: FibuLink Syndesmosis Repair System (K173550) Additional Predicates: Baby Gorilla®/Gorilla® Plating System (K203511) TRIMit Screw System (K04118… | 2017 |
| * | K203511 | Baby Gorilla/Gorilla Plating SystemSummary page 5…bearing. The implants can be used in conjunction with the Baby Gorilla®/Gorilla® Plating System (K203511). Predicate Device: FibuLink Syndesmosis Repair System (K173550) Additional Predicates: Baby Gorilla®/Gorilla® Plati… | 2020 |
| * | K041189 | Arthrex Trimit FamilySummary page 5…FibuLink Syndesmosis Repair System (K173550) Additional Predicates: Baby Gorilla®/Gorilla® Plating System (K203511) TRIMit Screw System (K041189) ZipTight System (K130033) Substantial The R3ACT™ Stabilization System is substantially… | 2004 |
| * | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Summary page 5…ditional Predicates: Baby Gorilla®/Gorilla® Plating System (K203511) TRIMit Screw System (K041189) ZipTight System (K130033) Substantial The R3ACT™ Stabilization System is substantially Equivalence: equivalent to the legally… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223589 | Grappler Suture Anchor R3FLEX IOL System | 2023 | 2 |
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 31 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 66 ancestors have a recall of any class.
- Of its descendants, K223589 (Paragon 28, Inc., 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The R3ACT™ Stabilization System is intended as an adjunct in fracture repair and ligamentous injuries of small bones of the feet and ankles including the distal tibia, distal fibula, talus, and calcaneus, and as an adjunct in external and intramedullary fixation systems involving plates and rods. Specifically, the R3ACT™ Stabilization System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
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/K211770 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211770: R3ACT Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211770
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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