Cleared Traditional

K120279 - NANOFUSE DBM

K120279 is an FDA 510(k) clearance for NANOFUSE DBM, manufactured by Nanotherapeutics. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K120279 · Nanotherapeutics · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
67d
Days
Class 2
Risk

K120279 is an FDA 510(k) clearance for the NANOFUSE DBM. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Nanotherapeutics (Alachua, US). The FDA issued a Cleared decision on April 6, 2012 after a review of 67 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.

FDA 510(k) Submission Details - K120279

510(k) Number K120279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2012
Decision Date April 06, 2012
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K120279.
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
K121989 · Exactech, Inc. · Nov 2012
BICERA (TM) RESORBABLE BONE SUBSTITUTE
K110949 · Wiltrom Corporation Limited · Sep 2012
KENSEY NASH BONE VOID FILLER XC
K120141 · Kensey Nash Cororation · May 2012
APACERAM BONE GRAFT SUBSTITUTE
K120602 · Hoya Corporation · Mar 2012
B-GENIN, R-GENIN
K113791 · Berkeley Advanced Biomaterials, Inc. · Mar 2012
POLYFUSE - NEUROBONE
K111018 · Atpac Medical, LLC · Feb 2012
K120279 · NANOFUSE DBM
Download PDF FDA Summary Nanotherapeutics