# K250867: Dunamis Screw and Suture Locking System

- Pathway: 510(k) (Traditional)
- Applicant: Dunamis Medical, LLC
- Decided: Aug 15, 2025 after 144 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 16 generations back to K961555 (1996). 217 ancestors in all.
No later device cites it as a predicate yet.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143702: Arthrex Blunt Tip Screws with Fiber Tape, Arthrex, Inc. (2015) Summary page 5.
- K191319: Dunamis Fixation Button System, Dunamis, LLC (2019) Summary page 5.
- K241235: Arthrex TightRope II, Arthrex, Inc. (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250867
Methodology: https://510kreport.com/methodology