Cleared Abbreviated

K190245 - PDS Barbed Suture, PDO MAXX Threads (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K190245 · Pdo Max, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
118d
Days
Class 2
Risk

K190245 is an FDA 510(k) clearance for the PDS Barbed Suture, PDO MAXX Threads. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Pdo Max, Inc. (Liverpool, US). The FDA issued a Cleared decision on June 4, 2019 after a review of 118 days - within the typical 510(k) review window.

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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pdo Max, Inc. devices

Submission Details

510(k) Number K190245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2019
Decision Date June 04, 2019
Days to Decision 118 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 114d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

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 K190245.
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K251414 · Feeltech Co., Ltd. · Oct 2025
V-soft Line™ Barbed Surgical Suture (Various)
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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