Cleared Abbreviated

PDS Barbed Suture, PDO MAXX Threads (K190245) - 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · 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 Consultant

Medical Device Academy, Inc.
Mary Vater

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 26
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K190245.
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · Ethicon, Inc. · Mar 2020
DemeDIOX Barbed Absorbable Surgical Suture
K191361 · Demetech Corporation · Nov 2019
Viola
K190264 · Meditime Co., Ltd. · Aug 2019
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
K182873 · Ethicon, Inc. · Jan 2019
Miracu
K172602 · Feeltech Co., Ltd. · Nov 2018
DemeTECH DemeDIOX absorbable surgical suture
K181582 · Demetech Corporation · Aug 2018