Cleared Abbreviated

K142070 - FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K142070 · Rti Surgical, Inc. · General & Plastic Surgery device
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Oct 2014
Decision
89d
Days
Class 2
Risk

K142070 is an FDA 510(k) clearance for the FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on October 27, 2014 after a review of 89 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rti Surgical, Inc. devices

Submission Details

510(k) Number K142070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2014
Decision Date October 27, 2014
Days to Decision 89 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 114d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

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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