Cleared Traditional

K023553 - MASTERGRAFT MATRIX

K023553 is the FDA 510(k) clearance for MASTERGRAFT MATRIX by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K023553 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2003
Decision
181d
Days
Class 2
Risk

K023553 is an FDA 510(k) clearance for the MASTERGRAFT MATRIX. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on April 22, 2003 after a review of 181 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K023553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2002
Decision Date April 22, 2003
Days to Decision 181 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 233
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K023553.
EXACTECH RESORBABLE BONE PASTE
K020078 · Exactech, Inc. · Feb 2004
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · Biomet Orthopedics, Inc. · Nov 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · Wrightmedicaltechnologyinc · Jul 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336 · Wrightmedicaltechnologyinc · Mar 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · Biomet, Inc. · Feb 2003
JAX
K010555 · Smith & Nephew, Inc. · Feb 2003