# K113004: PDS (TM) Barbed Sutures

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 20, 2011 after 74 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K014153 (2002). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061037: PDS Plus Antibacterial Suture, ETHICON, Inc. (2006) Summary page 1.
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo), Surgical Specialties Corp (2008) Summary page 1.
- (no number) PDS II (polydioxanone) Suture: named in the summary without a submission number

## Most influential descendants
- K191361: DemeDIOX Barbed Absorbable Surgical Suture (2019), 0 descendants of its own

## Recalls of this device
- Sep 25, 2013 · Class II · Z-0458-2014: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.

## Indications for use
PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K113004
Methodology: https://510kreport.com/methodology