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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K080736.
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · Novabone Products, LLC · May 2008
OSFERION
K080065 · Olympus Terumo Biomaterials Corporation · May 2008
PLEXUR-P
K080511 · Osteotech, Inc. · Apr 2008
COMPORUS
K062691 · Takiron Co., Ltd. · Apr 2008
WELLGRAFT PE II
K072170 · Gwowei Technology Co., Ltd. · Apr 2008
WELLGRAFT PE I
K072444 · Gwowei Technology Co., Ltd. · Apr 2008
K080736 · ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
Download PDF FDA Summary Apatech , Ltd.