Cleared Traditional

K071912 - APACERAM BONE GRAFT SUBSTITUTE

K071912 is an FDA 510(k) clearance for APACERAM BONE GRAFT SUBSTITUTE, manufactured by Pentax Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K071912 · Pentax Corp. · Orthopedic device
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Oct 2007
Decision
110d
Days
Class 2
Risk

K071912 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 Pentax Corp. (Chevy Chase, US). The FDA issued a Cleared decision on October 29, 2007 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentax Corp. devices

FDA 510(k) Submission Details - K071912

510(k) Number K071912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2007
Decision Date October 29, 2007
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 310
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K071912.
CAP PLUS
K063050 · Etex Corp. · Nov 2007
POLYGRAFT BGS
K062607 · Smith & Nephew, Inc. · Nov 2007
MASTERGRAFT PUTTY
K071813 · Medtronic Sofamor Danek · Nov 2007
SYNTHES CHRONOS COMPOSITE
K071046 · Synthes (Usa) · Oct 2007
A-BSM BONE SUBSTITUTE MATERIAL
K072636 · Etex Corp. · Oct 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597 · Wrightmedicaltechnologyinc · Oct 2007