Cleared Traditional

K173143 - Phasix ST Mesh (FDA 510(k) Clearance)

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

K173143 · C.R. Bard, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
208d
Days
Class 2
Risk

K173143 is an FDA 510(k) clearance for the Phasix ST Mesh. Classified as Mesh, Surgical, Absorbable, Abdominal Hernia (product code OWT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on April 25, 2018 after a review of 208 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K173143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date April 25, 2018
Days to Decision 208 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 114d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair.
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 - OWT Mesh, Surgical, Absorbable, Abdominal Hernia

All 10
Devices cleared under the same product code (OWT) and FDA review panel - the closest regulatory comparables to K173143.
Phasix ST Umbilical Hernia Patch
K243241 · Davol, Inc., A Subsidiary of C.R. Bard, Inc. · Feb 2025
Transorb™ Self-Gripping Resorbable Mesh
K233661 · Sofradim Production · Feb 2024
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
K191749 · Novus Scientific AB · Mar 2020
Phasix ST Mesh with Open Positioning System
K190185 · C.R. Bard, Inc. · Jun 2019