Cleared Traditional

K071849 - ALLOFUSE GEL AND PUTTY

K071849 is an FDA 510(k) clearance for ALLOFUSE GEL AND PUTTY, manufactured by Allosource, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 518-day FDA review.

K071849 · Allosource, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
518d
Days
Class 2
Risk

K071849 is an FDA 510(k) clearance for the ALLOFUSE GEL AND PUTTY. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Allosource, Inc. (Centennial, US). The FDA issued a Cleared decision on December 4, 2008 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Allosource, Inc. devices

FDA 510(k) Submission Details - K071849

510(k) Number K071849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2007
Decision Date December 04, 2008
Days to Decision 518 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
396d slower than avg
Panel avg: 122d · This submission: 518d
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K071849.
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K082672 · Novabone Products, LLC · Dec 2008
PROGENIX PLUS
K082002 · Medtronic Sofamor Danek · Nov 2008
GENEX
K082381 · Biocomposites, Ltd. · Nov 2008
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K083033 · Orthovita, Inc. · Nov 2008