Cleared Special

K080736 - ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE

K080736 is an FDA 510(k) clearance for ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE, manufactured by Apatech , Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 30-day FDA review.

K080736 · Apatech , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
30d
Days
Class 2
Risk

K080736 is an FDA 510(k) clearance for the ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE. 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 April 16, 2008 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Apatech , Ltd. devices

FDA 510(k) Submission Details - K080736

510(k) Number K080736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date April 16, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K080736.
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
K081439 · Orthovita, Inc. · Jun 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · Novabone Products, LLC · May 2008
PLEXUR-P
K080511 · Osteotech, Inc. · Apr 2008
PLEXUR M
K073405 · Osteotech, Inc. · Mar 2008
PROGENIX DMB PUTTY
K072265 · Medtronic Sofamor Danek · Jan 2008
MICROFUSE BONE VOID FILLER
K071187 · Globus Medical, Inc. · Dec 2007