# K190777: DemeTECH DemeFORCE Nonabsorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corporation
- Decided: Jul 31, 2019 after 127 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: 8 generations back to K904436 (1990). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150438: Force Fiber OrthoTape suture, Teleflexmedical, Inc. (2015) Summary page 4.
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 4.

## Indications for use
DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Source page: https://510kreport.com/device/K190777
Methodology: https://510kreport.com/methodology