# K150327: Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2

- Pathway: 510(k) (Traditional)
- Applicant: Dunamis, LLC
- Decided: Jun 29, 2015 after 139 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K990088 (1999). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 4.

## Indications for use
The Dunamis Force DFX Sutures, Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries

Source page: https://510kreport.com/device/K150327
Methodology: https://510kreport.com/methodology