Cleared Traditional

K052494 - NOVABONE-BIOACTIVE SYNTHETIC GRAFT

K052494 is an FDA 510(k) clearance for NOVABONE-BIOACTIVE SYNTHETIC GRAFT, 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 52-day FDA review.

K052494 · Novabone Products, LLC · Orthopedic device
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Nov 2005
Decision
52d
Days
Class 2
Risk

K052494 is an FDA 510(k) clearance for the NOVABONE-BIOACTIVE SYNTHETIC 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 November 3, 2005 after a review of 52 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

FDA 510(k) Submission Details - K052494

510(k) Number K052494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2005
Decision Date November 03, 2005
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
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 435
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K052494.
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
GENEROS 80, GENEROS 60
K051914 · Berkeley Advanced Biomaterials, Inc. · Nov 2005
MERRIES UNI-OSTEO, MODEL CS30250-CS10102
K051698 · Merries International, Inc. · Sep 2005
CERAMENT BONE VOID FILLER
K051951 · Bonesupport AB · Sep 2005
CONNEXUS, .5CC, MODEL 023000-005
K052098 · Isotis Orthobiologics, Inc. · Sep 2005