# K063778: Force Fiber Polyethylene Nonabsorbable Suture

- Pathway: 510(k) (Abbreviated)
- Applicant: Teleflex Medical
- Decided: Feb 9, 2007 after 50 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990088 (1999). 13 ancestors in all.
69 later devices descend from it; 17 cite it directly.
0 of 83 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 1.
- K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture, Teleflex Medical (2004) Summary page 1.
- K050947: Modification to: Modified Uss Polypropylene Suture, United States Surgical, A Division of Tyco Healthc (2005) Summary page 1.
- K021434: Arthrex Fiberwire in Usp Sizes, Arthrex, Inc. (2002) Summary page 2.

## Most influential descendants
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures (2009), 29 descendants of its own
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture (2007), 23 descendants of its own
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need (2010), 15 descendants of its own
- K150438: Force Fiber OrthoTape suture (2015), 14 descendants of its own
- K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (2018), 10 descendants of its own

## Recalls of this device
- Mar 11, 2014 · Class II · Z-1559-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

## Indications for use
Force Fiber® 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/K063778
Methodology: https://510kreport.com/methodology