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PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

by Ethicon Inc.

510(k) K212380

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212380 Date22 Feb 2022ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2147-2024 FDA Class II initiated 10 May 2024

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
510(k) Number
FDA product code
NEW
FDA applicant
ETHICON, Inc.
Device class
Class II
Regulation
21 CFR Part 878.4840
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is a synthetic, absorbable suture composed of polydioxanone, designed for approximating tissue layers such as the peritoneum, fascia, and skin. The suture incorporates an antibacterial coating of triclosan to inhibit bacterial colonization and biofilm formation on its surface, enhancing surgical site integrity.

This device is supplied sterile and intended for single-use in surgical settings. It is classified as a Class II medical device under FDA 510(k) clearance (K212380) and is manufactured by Ethicon Inc. The polydioxanone material is nonantigenic and nonpyrogenic, ensuring minimal tissue reaction during absorption. Available in multiple sizes, it adheres to regulatory standards for absorbable sutures and is intended for general and plastic surgery applications.

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PDS Plus Antibacterial (Polydioxanone) Suture used for?

    This suture is designed for approximating tissue layers such as the peritoneum, fascia, and skin during surgical procedures. The polydioxanone material provides strength and absorbability, while the antibacterial coating of triclosan helps inhibit bacterial colonization and biofilm formation, supporting surgical site integrity and reducing infection risk.

  • How is the PDS Plus Antibacterial Suture supplied and intended for use?

    The suture is supplied sterile and intended exclusively for single-use in surgical settings. It is not meant for reuse, as this could compromise sterility and effectiveness. The sterile packaging ensures it remains uncontaminated until use.

  • Is the PDS Plus Antibacterial Suture reusable or single-use?

    This suture is strictly for single-use only. Reusing absorbable sutures like this can introduce contamination risks, compromise sterility, and alter the material properties, potentially leading to adverse tissue reactions or failure during surgery.

  • What sizes and models are available for the PDS Plus Antibacterial Suture?

    The suture is available in multiple sizes, as indicated by the extensive list of registration numbers (e.g., 3003639970, 3013529787, etc.) in the FDA database. These correspond to different suture gauges and lengths tailored for various surgical applications in general and plastic surgery.

  • How should the PDS Plus Antibacterial Suture be stored?

    The suture should be stored in its original, unopened sterile packaging to maintain sterility. It must be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Always check the expiration date on the packaging before use.