# K042141: Polyglytone 6211 Synthetic Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Sep 28, 2004 after 50 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K885018 (1989). 5 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013671: L-25 Absorbable Surigcal Suture, United States Surgical, A Division of Tyco Healthc (2002) Summary page 2.
- K032586: Caprosyn Absorbable Suture, United States Surgical, A Division of Tyco Healthc (2003) Summary page 2.

## Most influential descendants
- 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
- 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

## Indications for use
Polyglytone* 6211™ Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Source page: https://510kreport.com/device/K042141
Methodology: https://510kreport.com/methodology