Cleared Traditional

K032268 - MBCP

K032268 is an FDA 510(k) clearance for MBCP, manufactured by Biomatlante. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K032268 · Biomatlante · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
141d
Days
Class 2
Risk

K032268 is an FDA 510(k) clearance for the MBCP. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biomatlante (Vigneux De Bretagne, FR). The FDA issued a Cleared decision on December 11, 2003 after a review of 141 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 Biomatlante devices

FDA 510(k) Submission Details - K032268

510(k) Number K032268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2003
Decision Date December 11, 2003
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K032268.
ALLOMATRIX MODEL# 86
K020895 · Wrightmedicaltechnologyinc · Mar 2004
EXACTECH RESORBABLE BONE PASTE
K020078 · Exactech, Inc. · Feb 2004
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288 · Orthovita, Inc. · Dec 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · Etex Corp. · Dec 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · Biomet Orthopedics, Inc. · Nov 2003
VITOSS-FILLED CARTRIDGE
K032130 · Orthovita, Inc. · Nov 2003