Cleared Traditional

K041613 - NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE

K041613 is an FDA 510(k) clearance for NOVABONE - AR - RESORBABLE BONE GRAFT S..., 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 71-day FDA review.

K041613 · Novabone Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
71d
Days
Class 2
Risk

K041613 is an FDA 510(k) clearance for the NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE. 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 August 25, 2004 after a review of 71 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 - K041613

510(k) Number K041613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date August 25, 2004
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 K041613.
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc · Sep 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · Biomet Manufacturing, Inc. · Aug 2004
NAME BONE VOID FILLER
K041421 · Stryker Biotech · Aug 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
K041616 · Orthos (Uk) Limited · Aug 2004
CEMENTEK
K041493 · Teknimed, S.A. · Aug 2004
TRI-OSTETIC
K041889 · Berkeley Advanced Biomaterials, Inc. · Aug 2004