Cleared Special

K090731 - NOVABONE POROUS - SYNTHETIC BONE GRAFT ...

K090731 is the FDA 510(k) clearance for NOVABONE POROUS - SYNTHETIC BONE GRAFT ... by Novabone Products, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Special 510(k) pathway after a 27-day FDA review.

K090731 · Novabone Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
27d
Days
Class 2
Risk

K090731 is an FDA 510(k) clearance for the NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Novabone Products, LLC (Alachua, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Novabone Products, LLC devices

Submission Details

510(k) Number K090731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date April 15, 2009
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 249
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K090731.
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K083270 · Wrightmedicaltechnologyinc · Aug 2009
E-MATRIX GRAFT BONE EXTENDER
K083449 · Pioneer Surgical Technology · Jun 2009
MASTERGRAFT STRIP
K082166 · Medtronic Sofamor Danek · Jun 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K082672 · Novabone Products, LLC · Dec 2008