Cleared Traditional

K122306 - SYNOVIS COLLAGEN MATRIX (TBD)

K122306 is an FDA 510(k) clearance for SYNOVIS COLLAGEN MATRIX (TBD), manufactured by Synovis Surgical Innovations. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K122306 · Synovis Surgical Innovations · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
219d
Days
Class 2
Risk

K122306 is an FDA 510(k) clearance for the SYNOVIS COLLAGEN MATRIX (TBD). Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122306

510(k) Number K122306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2012
Decision Date March 08, 2013
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 83
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K122306.
VASCU-GUARD Peripheral Vascular Patch
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K140789 · Cormatrix Cardiovascular, Inc. · Jul 2014
CARDIOCEL
K130872 · Celxcel Pty, Ltd. · Jan 2014
SMI CARDIOVASCULAR PATCH
K122105 · Solinas Medical, Inc. · Dec 2012
SMI CARDIOVASCULAR PACH
K112683 · Solimas Medical, Inc. · Dec 2011
PATCH, PLEDGET AND INTRACARDIAC
K111187 · Cormatrix Cardiovascular, Inc. · Jul 2011
K122306 · SYNOVIS COLLAGEN MATRIX (TBD)
Download PDF FDA Summary Synovis Surgical Inno…