Cleared Special

K110368 - NOVABONE PUTTY - BIOACTIVE SYNTHETIC BO...

K110368 is the FDA 510(k) clearance for NOVABONE PUTTY - BIOACTIVE SYNTHETIC BO... by Novabone Products, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Special 510(k) pathway after a 65-day FDA review.

K110368 · Novabone Products, LLC · Orthopedic device
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Apr 2011
Decision
65d
Days
Class 2
Risk

K110368 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 April 14, 2011 after a review of 65 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 K110368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2011
Decision Date April 14, 2011
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 247
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K110368.
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
K112773 · Novabone Products, LLC · Oct 2011
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925 · Novabone Products, LLC · Jul 2011
FORTROSS BONE VOID FILLER
K110561 · Pioneer Surgical Technology · Apr 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · Synthes USA Products, LLC · Jan 2011
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392 · Globus Medical, Inc. · Dec 2010
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
K101860 · Novabone Products, LLC · Sep 2010