Cleared Special

K120602 - APACERAM BONE GRAFT SUBSTITUTE

K120602 is an FDA 510(k) clearance for APACERAM BONE GRAFT SUBSTITUTE, manufactured by Hoya Corporation. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 24-day FDA review.

K120602 · Hoya Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
24d
Days
Class 2
Risk

K120602 is an FDA 510(k) clearance for the APACERAM BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Hoya Corporation (Chevy Chase, US). The FDA issued a Cleared decision on March 23, 2012 after a review of 24 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 - K120602

510(k) Number K120602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date March 23, 2012
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 K120602.
BICERA (TM) RESORBABLE BONE SUBSTITUTE
K110949 · Wiltrom Corporation Limited · Sep 2012
KENSEY NASH BONE VOID FILLER XC
K120141 · Kensey Nash Cororation · May 2012
NANOFUSE DBM
K120279 · Nanotherapeutics · Apr 2012
B-GENIN, R-GENIN
K113791 · Berkeley Advanced Biomaterials, Inc. · Mar 2012
POLYFUSE - NEUROBONE
K111018 · Atpac Medical, LLC · Feb 2012
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
K112383 · Skeletal Kinetics, LLC · Feb 2012
K120602 · APACERAM BONE GRAFT SUBSTITUTE
Download PDF FDA Summary Hoya Corporation