Cleared Traditional

K163310 - NovaBone IRM

K163310 is the FDA 510(k) clearance for NovaBone IRM by Novabone Products, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K163310 · Novabone Products, LLC · Orthopedic device
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Jan 2017
Decision
56d
Days
Class 2
Risk

K163310 is an FDA 510(k) clearance for the NovaBone IRM. 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 January 18, 2017 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Novabone Products, LLC devices

Submission Details

510(k) Number K163310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2016
Decision Date January 18, 2017
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
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 233
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K163310.
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MASTERGRAFT Contain
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MASTERGRAFT MATRIX EXT
K141824 · Medtronic Sofamor Danek, Inc. · Sep 2014
CONFIRM BIOACTIVE
K133678 · Globus Medical, Inc. · Aug 2014