PDS(TM) BARBED SUTURES— 510(k) K113004

Clearance details

Applicant

ETHICON, Inc.

Product code

Code NEW

Device class

Class 2

Regulation

21 CFR 878.4840

Advisory panel

General, Plastic Surgery

Date received

2011-10-07

Decision date

2011-12-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Somerville, NJ, US

• K253879 — MONOFIX PDO2026-08-25
• K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture2026-07-09
• K252171 — Barbed PDO Suture2026-06-12
• K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18
• K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture2025-11-12

• K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture2026-06-25
• K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device2026-03-27
• K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture2026-02-06
• K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device2025-12-22
• K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device2022-11-15

Death

32

Injury

2,179

Malfunction

8,975

Total

11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0458-2014 — Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.Class II·Terminated·Ethicon, Inc.·20130925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113004.