510(k) · Cleared
ClearedDunamis Screw and Suture Locking System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dunamis Medical, LLC · HWC Screw, Fixation, Bone
Cleared on Aug 15, 2025 as substantially equivalent to K143702 (Arthrex, Inc., 2015) and 2 other predicates after a 144-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Aug 15, 2025
- Review
- 144 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K961555 (1996). 217 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 12 generations between
- 3 generations backK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
- 2 generations backK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
- 1 generation backK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- This deviceK250867 Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025
Show all 16 generations
- Root · 16 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 15 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 14 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 13 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 12 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 11 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 10 generations backK112237 Microsuture AnchorsArthrex, Inc. · 2011
- 9 generations backK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
- 8 generations backK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
- 7 generations backK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018
- 6 generations backK200341 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- 5 generations backK203268 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2020
- 4 generations backK230568 FiberTak Suture AnchorArthrex, Inc. · 2023
- 3 generations backK231330 FiberTak® Suture AnchorArthrex, Inc. · 2023
- 2 generations backK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
- 1 generation backK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- This deviceK250867 Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −15 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −14 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −13 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −12 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −11 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −10 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| −9 | K140476 | Arthrex Fibertak Suture Anchor | Arthrex, Inc. | 2014 | — |
| −8 | K151230 | Arthrex FiberTak Anchors | Arthrex, Inc. | 2015 | — |
| −7 | K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2018 | — |
| −6 | K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| −5 | K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 | — |
| −4 | K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023 | — |
| −3 | K231330 | FiberTak® Suture Anchor | Arthrex, Inc. | 2023 | — |
| −2 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. | 2023 | — |
| −1 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
| 0 (this device) | K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 12 | 0 |
| 2000 | 15 | 0 |
| 2001 | 19 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 16 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K143702 | Arthrex Blunt Tip Screws with Fiber TapeSummary page 5…Manufacturer Device Name K Number Primary Arthrex Blunt Tip Screws with FiberTape K143702 Additional Dunamis Fixation Button System K191319 Additional Arthrex… | 2015 |
| * | K191319 | Dunamis Fixation Button SystemSummary page 5…Arthrex Blunt Tip Screws with FiberTape K143702 Additional Dunamis Fixation Button System K191319 Additional Arthrex TightRope II K241235 Reference Paragon 28, In… | 2019 |
| * | K241235 | Arthrex TightRope IISummary page 5…Dunamis Fixation Button System K191319 Additional Arthrex TightRope II K241235 Reference Paragon 28, Inc. Monster Screw System K203011 Reference Dunamis… | 2024 |
| † | K203011 | Monster Screw System | 2020 |
| † | K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | 2015 |
| † | K153746 | Dunamis Force DFX Tensile Tape | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 29 of the 217 ancestors have a recall of any class.
- 1 other device also cites its predicate K143702.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Dunamis Screws are intended to be used as stand-alone bone screws indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bone appropriate for the size of the device. When used in conjunction with Dunamis Force DFX Suture or Suture Tape, the Dunamis Screw and Suture Locking System is intended to be used for fixation of bone-to-bone or soft tissue-to-bone. The components are intended to…
Read the full statement (178 words)
The Dunamis Screws are intended to be used as stand-alone bone screws indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bone appropriate for the size of the device.
When used in conjunction with Dunamis Force DFX Suture or Suture Tape, the Dunamis Screw and Suture Locking System is intended to be used for fixation of bone-to-bone or soft tissue-to-bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, Dunamis will be offering these devices for use in orthopedic procedures, such as ACL/PCL repair and reconstruction for the adult and pediatric patient population when the device does not bridge, disrupt, or interfere with the growth plate; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, Quadriceps Tendon, PLC repair and reconstruction. When used in conjunction with the Dunamis Screws, the Suture Locking System can be used as a cerclage to treat bone fractures, such as patella, greater tuberosity, or olecranon fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250867: Dunamis Screw and Suture Locking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250867
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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