Cleared Special

K071206 - ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE

K071206 is an FDA 510(k) clearance for ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT S..., 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.

K071206 · Apatech , Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
30d
Days
Class 2
Risk

K071206 is an FDA 510(k) clearance for the ACTIFUSE ABX E-Z-FIL PUTTY 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 May 31, 2007 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 - K071206

510(k) Number K071206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2007
Decision Date May 31, 2007
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 K071206.
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630 · Etex Corp. · Jun 2007
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
K070864 · Biomet Osteobiologics · Jun 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237 · Kensey Nash Corp. · Jun 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007
PRO OSTEON 500R
K063346 · Ebi, L.P. · Apr 2007
INQU
K063359 · Isto Technologies, Inc. · Apr 2007
K071206 · ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
Download PDF FDA Summary Apatech , Ltd.