# K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical
- Decided: Mar 10, 2010 after 16 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
No predicates in its family tree.
26 later devices descend from it; 8 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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
- K132867: Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with Inserter, 2.2MM (2013), 7 descendants of its own
- K151068: SureLock W Suture Anchor (2015), 6 descendants of its own
- K230311: HyperSuture (2023), 4 descendants of its own

## 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/K100506
Methodology: https://510kreport.com/methodology