Cleared Traditional

XYLOS MACRO-POROUS SURGICAL MESH (K111584) - FDA 510(k) Clearance

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

K111584 · Xylos Corporation · General & Plastic Surgery device
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Aug 2011
Decision
79d
Days
Class 2
Risk

K111584 is an FDA 510(k) clearance for the XYLOS MACRO-POROUS SURGICAL MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Xylos Corporation (Langhorne, US). The FDA issued a Cleared decision on August 25, 2011 after a review of 79 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

Submission Details

510(k) Number K111584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2011
Decision Date August 25, 2011
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 162
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