Cleared Traditional

TIGR Matrix Surgical Mesh (K163005) - FDA 510(k) Clearance

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

K163005 · Novus Scientific AB · General & Plastic Surgery device
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Jul 2017
Decision
272d
Days
Class 2
Risk

K163005 is an FDA 510(k) clearance for the TIGR Matrix Surgical Mesh. Classified as Mesh, Surgical, Absorbable, Abdominal Hernia (product code OWT), Class II - Special Controls.

Submitted by Novus Scientific AB (Uppsala, SE). The FDA issued a Cleared decision on July 27, 2017 after a review of 272 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 Novus Scientific AB devices

Submission Details

510(k) Number K163005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date July 27, 2017
Days to Decision 272 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
157d slower than avg
Panel avg: 115d · This submission: 272d
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 K163005.
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
GORE BIO-A Tissue Reinforcement
K191773 · W.L. Gore & Associates, Inc. · Jul 2019
Phasix ST Mesh with Open Positioning System
K190185 · C.R. Bard, Inc. · Jun 2019
Phasix ST Mesh
K173143 · C.R. Bard, Inc. · Apr 2018