Cleared Special

K082672 - NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE...

K082672 is the FDA 510(k) clearance for NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE... by Novabone Products, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Special 510(k) pathway after a 85-day FDA review.

K082672 · Novabone Products, LLC · Orthopedic device
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Dec 2008
Decision
85d
Days
Class 2
Risk

K082672 is an FDA 510(k) clearance for the NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT. 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 December 9, 2008 after a review of 85 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 K082672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date December 09, 2008
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K082672.
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
K090731 · Novabone Products, LLC · Apr 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008
PROGENIX PLUS
K082002 · Medtronic Sofamor Danek · Nov 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · Baxter Healthcare Corp · Oct 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442 · Globus Medical, Inc. · Oct 2008