Cleared Traditional

PDO Max Suture with Dual Needle (K210871) - FDA 510(k) Clearance

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

K210871 · Pdo Max, Inc. · General & Plastic Surgery device
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Dec 2021
Decision
268d
Days
Class 2
Risk

K210871 is an FDA 510(k) clearance for the PDO Max Suture with Dual Needle. 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 December 17, 2021 after a review of 268 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 Pdo Max, Inc. devices

Submission Details

510(k) Number K210871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2021
Decision Date December 17, 2021
Days to Decision 268 days
Submission Type Traditional
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
153d slower than avg
Panel avg: 115d · This submission: 268d
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 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 K210871.
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
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
K212380 · Ethicon, Inc. · Feb 2022
WEGO-PDO Barbed Suture
K201139 · Foosin Medical Supplies Inc., Ltd. · Oct 2020
MINT Product Family
K192423 · Hans Biomed Corporation · Sep 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · Ethicon, Inc. · Mar 2020