Cleared Traditional

K060432 - NOVABONE POROUS-BONE GRAFT SCAFFOLD

K060432 is an FDA 510(k) clearance for NOVABONE POROUS-BONE GRAFT SCAFFOLD, 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 42-day FDA review.

K060432 · Novabone Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
42d
Days
Class 2
Risk

K060432 is an FDA 510(k) clearance for the NOVABONE POROUS-BONE GRAFT SCAFFOLD. 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 April 4, 2006 after a review of 42 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 - K060432

510(k) Number K060432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2006
Decision Date April 04, 2006
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 K060432.
OSTEO-LINK BONE VOID FILLER PELLETS
K060809 · Promed Advance Technology Co., Ltd. · Jul 2006
BIO 1-KIT BIOSORB FILLED CARTRIDGE
K061022 · Science For Biomaterials · May 2006
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
K060728 · Novabone Products, LLC · May 2006
NORIAN SRS BONE VOID FILLER
K060408 · Synthes (Usa) · Mar 2006
NORIAN SRS FAST SET PUTTY
K060406 · Synthes (Usa) · Mar 2006
COLLOSS E BONE VOID FILLER
K051047 · Ossacur AG · Mar 2006