510(k) · Cleared
ClearedDunamis Fixation Button System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dunamis, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 29, 2019 as substantially equivalent to K043248 (Arthrex, Inc., 2005) and 5 other predicates after a 106-day review. Its family tree reaches back 13 generations to 1979. 1 later device descends from it.
- Decided
- Aug 29, 2019
- Review
- 106 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K792022 (1979). 62 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations between
- 3 generations backK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- 2 generations backK160655 OrthoButton CLRiverpoint Medical · 2016
- 1 generation backK171060 OrthoButton ALRiverpoint Medical · 2017
- This deviceK191319 Dunamis Fixation Button SystemDunamis, LLC · 2019
- Descendant · cites it directly · 0 of its ownK250867 Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025
Show all 13 generations
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 12 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 11 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 10 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 9 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 8 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 7 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 6 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 5 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 4 generations backK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- 3 generations backK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- 2 generations backK160655 OrthoButton CLRiverpoint Medical · 2016
- 1 generation backK171060 OrthoButton ALRiverpoint Medical · 2017
- This deviceK191319 Dunamis Fixation Button SystemDunamis, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −12 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −11 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −10 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −9 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −8 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −7 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −6 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −5 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| −4 | K090923 | Parcus Graft Fixation System | Parcus Medical, LLC | 2009 | — |
| −3 | K133757 | GFS II Standard, GFS II Large, GFS Mimi | Parcus Medical, LLC | 2014 | — |
| −2 | K160655 | OrthoButton CL | Riverpoint Medical | 2016 | — |
| −1 | K171060 | OrthoButton AL | Riverpoint Medical | 2017 | — |
| 0 (this device) | K191319 | Dunamis Fixation Button System | Dunamis, LLC | 2019 | — |
| +1 | K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (6)
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 |
|---|---|---|---|
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 5…The Dunamis Fixation Button System is substantially equivalent to the following predicates with respect to indications, design, material and function: Arthrex TightRope (K043248, K052776, K112990), RiverPoint OrthoButton CL (K160655), RiverPoint OrthoButton AL (K171060) and Smith & Nephew Ultraslide Acromi… | 2005 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 5…is Fixation Button System is substantially equivalent to the following predicates with respect to indications, design, material and function: Arthrex TightRope (K043248, K052776, K112990), RiverPoint OrthoButton CL (K160655), RiverPoint OrthoButton AL (K171060) and Smith & Nephew Ultraslide Acromioclavicul… | 2005 |
| * | K112990 | Acl Tightrope,Acl Tightrope Duuble BundleSummary page 5…on Button System is substantially equivalent to the following predicates with respect to indications, design, material and function: Arthrex TightRope (K043248, K052776, K112990), RiverPoint OrthoButton CL (K160655), RiverPoint OrthoButton AL (K171060) and Smith & Nephew Ultraslide Acromioclavicular and Sy… | 2011 |
| * | K160655 | OrthoButton CLSummary page 5…ivalent to the following predicates with respect to indications, design, material and function: Arthrex TightRope (K043248, K052776, K112990), RiverPoint OrthoButton CL (K160655), RiverPoint OrthoButton AL (K171060) and Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device (K082095). Th… | 2016 |
| * | K171060 | OrthoButton ALSummary page 5…ith respect to indications, design, material and function: Arthrex TightRope (K043248, K052776, K112990), RiverPoint OrthoButton CL (K160655), RiverPoint OrthoButton AL (K171060) and Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device (K082095). The sutures proposed for use with the s… | 2017 |
| * | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSummary page 5…052776, K112990), RiverPoint OrthoButton CL (K160655), RiverPoint OrthoButton AL (K171060) and Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device (K082095). The sutures proposed for use with the subject system are the same as those used with the reference device, Dunamis Force DFX Su… | 2008 |
| † | K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250867 | Dunamis Screw and Suture Locking System | 2025 | 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 40 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 62 ancestors have a recall of any class.
- Of its descendants, K250867 (Dunamis Medical, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 25 other devices also cite its predicate K043248.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Dunamis Fixation Button System is 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, the Dunamis Fixation Button System is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon repair/ reconstruction, including providing fixation during the healing process following acromioclavicular separations, as an adjunct to fracture repair in syndesmotic trauma, and ACL and PCL repair.
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/K191319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191319: Dunamis Fixation Button System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191319
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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