# K191268: Force Fiber Suture

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical Incorporated
- Decided: Jun 11, 2019 after 29 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: 7 generations back to K990088 (1999). 37 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 40 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.
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 5.
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture, Teleflexmedical, Inc. (2007) Summary page 5.
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures, Beere Precision Medical Instruments, Kmedic, Telef (2009) Summary page 5.
- K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK, Teleflex Medical (2010) Summary page 5.
- 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, Teleflex Medical Incorporated (2018) Summary page 5.

## Most influential descendants
- K210675: EasyWhip (2021), 1 descendant of its own
- K261021: EasyWhip Family (2026), 0 descendants of its own

## Indications for use
Force Fiber® 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 orthopedic surgeries.

Source page: https://510kreport.com/device/K191268
Methodology: https://510kreport.com/methodology