Cleared Traditional

K192144 - STRATAFIX Spiral PDS Plus Bidirectional...

K192144 is the FDA 510(k) clearance for STRATAFIX Spiral PDS Plus Bidirectional... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEW) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K192144 · Ethicon, Inc. · General & Plastic Surgery device
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Mar 2020
Decision
230d
Days
Class 2
Risk

K192144 is an FDA 510(k) clearance for the STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 25, 2020 after a review of 230 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

Submission Details

510(k) Number K192144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2019
Decision Date March 25, 2020
Days to Decision 230 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
115d slower than avg
Panel avg: 115d · This submission: 230d
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 27
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K192144.
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DemeDIOX Barbed Absorbable Surgical Suture
K191361 · Demetech Corporation · Nov 2019
Viola
K190264 · Meditime Co., Ltd. · Aug 2019
PDS Barbed Suture, PDO MAXX Threads
K190245 · Pdo Max, Inc. · Jun 2019