Cleared Traditional

K110925 - NOVABONE MACROPOR-SI+ - BIOACTIVE BONE ...

K110925 is the FDA 510(k) clearance for NOVABONE MACROPOR-SI+ - BIOACTIVE BONE ... by Novabone Products, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K110925 · Novabone Products, LLC · Orthopedic device
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Jul 2011
Decision
95d
Days
Class 2
Risk

K110925 is an FDA 510(k) clearance for the NOVABONE MACROPOR-SI+ - BIOACTIVE 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 July 5, 2011 after a review of 95 days - within the typical 510(k) review window.

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 Novabone Products, LLC devices

Submission Details

510(k) Number K110925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2011
Decision Date July 05, 2011
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 244
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K110925.
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · Medtronic Sofamor Danek, Inc. · Jan 2013
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K121989 · Exactech, Inc. · Nov 2012
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
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K110561 · Pioneer Surgical Technology · Apr 2011
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
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NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · Synthes USA Products, LLC · Jan 2011