Cleared Traditional

K080009 - NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT

K080009 is an FDA 510(k) clearance for NOVABONE PUTTY- 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 124-day FDA review.

K080009 · Novabone Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
124d
Days
Class 2
Risk

K080009 is an FDA 510(k) clearance for the NOVABONE PUTTY- 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 May 6, 2008 after a review of 124 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 - K080009

510(k) Number K080009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2008
Decision Date May 06, 2008
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 K080009.
GENEX PUTTY
K073341 · Biocomposites, Ltd. · Jul 2008
CERAMENT BONE VOID FILLER, MODEL A0210
K073316 · Bonesupport AB · Jun 2008
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
K081439 · Orthovita, Inc. · Jun 2008
OSFERION
K080065 · Olympus Terumo Biomaterials Corporation · May 2008
PLEXUR-P
K080511 · Osteotech, Inc. · Apr 2008
COMPORUS
K062691 · Takiron Co., Ltd. · Apr 2008