# K260775: Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical, LLC
- Decided: May 6, 2026 after 57 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: 8 generations back to K990088 (1999). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K172016: Force Fiber Fusion Suture, Teleflex Medical Incorporated (2017) Summary page 5.
- K231163: HS Fiber Sutures, Riverpoint Medical (2024) Summary page 5.
- K162310: XBraid TT Suture Tape, Stryker (2016) Summary page 5.

## Indications for use
Polyethylene Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Polyethylene Fusion Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Polyethylene OrthoTape™ 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/K260775
Methodology: https://510kreport.com/methodology