Cleared Traditional

VERITAS COLLAGEN MATRIX (K030879) - FDA 510(k) Clearance

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

K030879 · Synovis Surgical Innovations · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2003
Decision
35d
Days
Class 2
Risk

K030879 is an FDA 510(k) clearance for the VERITAS COLLAGEN MATRIX. Classified as Mesh, Surgical, Collagen, Staple Line Reinforcement (product code OXE), Class II - Special Controls.

Submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on April 24, 2003 after a review of 35 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 Synovis Surgical Innovations devices

Submission Details

510(k) Number K030879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2003
Decision Date April 24, 2003
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.
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.