Cleared Traditional

K140946 - NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE

K140946 is an FDA 510(k) clearance for NOVABONE MACROFORM BIOACTIVE PACKABLE, manufactured by Novabone Products, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K140946 · Novabone Products, LLC · Orthopedic device
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Aug 2014
Decision
130d
Days
Class 2
Risk

K140946 is an FDA 510(k) clearance for the NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE. 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 August 22, 2014 after a review of 130 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

FDA 510(k) Submission Details - K140946

510(k) Number K140946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date August 22, 2014
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 442
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K140946.
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
K141600 · Pioneer Surgical Technology, Inc. (Rti Surgical, I · Oct 2014
MASTERGRAFT MATRIX EXT
K141824 · Medtronic Sofamor Danek, Inc. · Sep 2014
CONFIRM BIOACTIVE
K133678 · Globus Medical, Inc. · Aug 2014
FIBERGRAFT BG MORSELS
K141956 · Prosidyan, Inc. · Aug 2014
SKAFFOLD NMX BONE VOID FILLER
K132211 · Skeletal Kinetics, LLC · Aug 2014
AS20 COMPOSITE GRAFT
K141746 · Wrightmedicaltechnologyinc · Aug 2014