Cleared Traditional

K141776 - STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES

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

K141776 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K141776

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.

NEW Device Classification - Class 2, Special Controls

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 66
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K141776.
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STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
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TRANQUILL BARBED DEVICE
K133420 · Surgical Specialties Corp. Dba Angiotech · Nov 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K132268 · Surgical Specialties Corporation Dba Angiotech · Aug 2013
MINT
K130191 · Hans Biomed Corporation · Jun 2013
K141776 · STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
Download PDF FDA Summary Ethicon, Inc.