Cleared Traditional

K082575 - ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES

K082575 is an FDA 510(k) clearance for ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX ..., manufactured by Apatech , Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K082575 · Apatech , Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2008
Decision
81d
Days
Class 2
Risk

K082575 is an FDA 510(k) clearance for the ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Apatech , Ltd. (Oregon City, US). The FDA issued a Cleared decision on November 25, 2008 after a review of 81 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 Apatech , Ltd. devices

FDA 510(k) Submission Details - K082575

510(k) Number K082575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2008
Decision Date November 25, 2008
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 K082575.
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