Cleared Traditional

K212380 - PDS Plus Antibacterial (Polydioxanone) ...

K212380 is an FDA 510(k) clearance for PDS Plus Antibacterial (Polydioxanone) ..., manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K212380 · Ethicon, Inc. · General & Plastic Surgery device
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Feb 2022
Decision
204d
Days
Class 2
Risk

K212380 is an FDA 510(k) clearance for the PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical S.... Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Raritan, US). The FDA issued a Cleared decision on February 22, 2022 after a review of 204 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

FDA 510(k) Submission Details - K212380

510(k) Number K212380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2021
Decision Date February 22, 2022
Days to Decision 204 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 115d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 30
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K212380.
1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K232246 · M/s. Meril Endo Surgery Private Limited. · Apr 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
K240389 · Hyundae Meditech Co., Ltd. · Mar 2024
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
K220549 · Hans Biomed Corporation · Mar 2023
PDO Max Suture with Dual Needle
K210871 · Pdo Max, Inc. · Dec 2021
WEGO-PDO Barbed Suture
K201139 · Foosin Medical Supplies Inc., Ltd. · Oct 2020
MINT Product Family
K192423 · Hans Biomed Corporation · Sep 2020