# K191319: Dunamis Fixation Button System

- Pathway: 510(k) (Traditional)
- Applicant: Dunamis, LLC
- Decided: Aug 29, 2019 after 106 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K792022 (1979). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 5.
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 5.
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle, Arthrex, Inc. (2011) Summary page 5.
- K160655: OrthoButton CL, Riverpoint Medical (2016) Summary page 5.
- K171060: OrthoButton AL, Riverpoint Medical (2017) Summary page 5.
- K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device, Smith & Nephew Endoscopy, Inc. (2008) Summary page 5.

## Most influential descendants
- K250867: Dunamis Screw and Suture Locking System (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K191319
Methodology: https://510kreport.com/methodology