# K141206: Edwards Lifesciences Thruport Knotting System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 16, 2015 after 252 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933887 (1993). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme, Lsi Solutions, Inc. (2010) Summary page 4.

## Most influential descendants
- K150882: Edwards Suture Fastening System (2015), 0 descendants of its own

## Indications for use
The knotting instrument used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot is indicated for use in the approximation of soft tissue and prosthetic materials.

Source page: https://510kreport.com/device/K141206
Methodology: https://510kreport.com/methodology