Cleared Traditional

K141776 - STRATAFIX SYMMETRIC PDS PLUS KNOTLESS T...

K141776 is the FDA 510(k) clearance for STRATAFIX SYMMETRIC PDS PLUS KNOTLESS T... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEW) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K141776 · Ethicon, Inc. · General & Plastic Surgery device
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Oct 2014
Decision
105d
Days
Class 2
Risk

K141776 is an FDA 510(k) clearance for the STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES. 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 October 15, 2014 after a review of 105 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 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 K141776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 02, 2014
Decision Date October 15, 2014
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 K141776.
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Omega VL
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DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284 · Coloplast A/S · May 2012
PDS(TM) BARBED SUTURES
K113004 · Ethicon, Inc. · Dec 2011
PDS PLUS ANTIBACTERIAL SUTURE
K061037 · Ethicon, Inc. · Jul 2006