Cleared Traditional

K243897 - PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243897 · Ethicon, Inc. · General & Plastic Surgery device
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Nov 2025
Decision
328d
Days
Class 2
Risk

K243897 is an FDA 510(k) clearance for the PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical.... 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 November 12, 2025 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K243897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2024
Decision Date November 12, 2025
Days to Decision 328 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
214d slower than avg
Panel avg: 114d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 61
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K243897.
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
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PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644 · M/s. Meril Endo Surgery Private Limited. · Sep 2025
Suture-TOOL System
K250977 · Suturion AB · Apr 2025
Suture-TOOL System
K242835 · Suturion AB · Jan 2025
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