# 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

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical Incorporated
- Decided: Oct 10, 2018 after 99 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: 6 generations back to K990088 (1999). 36 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 11.
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture, Teleflexmedical, Inc. (2007) Summary page 11.
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures, Beere Precision Medical Instruments, Kmedic, Telef (2009) Summary page 11.
- K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK, Teleflex Medical (2010) Summary page 11.
- K150438: Force Fiber OrthoTape suture, Teleflexmedical, Inc. (2015) Summary page 11.
- K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (1999) Summary page 11.
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (1999) Summary page 11.
- K030212: Monodek Synthetic Absorbable Surgical Suture, Genzyme Biosurgery (2003) Summary page 11.
- K042141: Polyglytone 6211 Synthetic Absorbable Suture, Teleflex Medical (2004) Summary page 11.

## Most influential descendants
- K230311: HyperSuture (2023), 4 descendants of its own
- K191268: Force Fiber Suture (2019), 2 descendants of its own
- K242201: HyperSuture White/Green Extension Line (2025), 1 descendant of its own
- K210675: EasyWhip (2021), 1 descendant of its own
- K261988: Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture (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. Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Source page: https://510kreport.com/device/K181774
Methodology: https://510kreport.com/methodology