# K151009: Nexus Suture

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Aug 18, 2015 after 125 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: 1 generation back to K033654 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033654: Force Fiber, Teleflex Medical (2004) Summary page 5.
- K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture, Teleflex Medical (2004) Summary page 5.

## Indications for use
Nexus™ 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/K151009
Methodology: https://510kreport.com/methodology