Cleared Traditional

K023553 - MASTERGRAFT MATRIX

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

K023553 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K023553

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.

MQV Device Classification - Class 2, Special Controls

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 425
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K023553.
VITOSS-FILLED CARTRIDGE
K032130 · Orthovita, Inc. · Nov 2003
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K032409 · Orthovita, Inc. · Aug 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