Cleared Traditional

K083823 - SECURIAN TISSUE REINFORCEMENT MATRIX

K083823 is an FDA 510(k) clearance for SECURIAN TISSUE REINFORCEMENT MATRIX, manufactured by Xylos Corporation. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K083823 · Xylos Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
86d
Days
Class 2
Risk

K083823 is an FDA 510(k) clearance for the SECURIAN TISSUE REINFORCEMENT MATRIX. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Xylos Corporation (Langhorne, US). The FDA issued a Cleared decision on March 18, 2009 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xylos Corporation devices

FDA 510(k) Submission Details - K083823

510(k) Number K083823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date March 18, 2009
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTM Mesh, Surgical

All 152
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K083823.
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
K091142 · Rti Biologics, Inc. · Aug 2009
XYLOS POROUS SURGICAL MESH
K090880 · Xylos Corporation · May 2009
MTA PROTECTIVE SHEET
K090778 · Xylos Corporation · Apr 2009
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K082682 · Cook Biotech, Inc. · Feb 2009
SURGIMEND
K083898 · Tei Biosciences, Inc. · Feb 2009
VERITAS COLLAGEN MATRIX (DRY)
K083039 · Synovis Surgical Innovations · Nov 2008