Cleared Traditional

K063527 - MBCP+

K063527 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 250-day FDA review.

K063527 · Biomatlante · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
250d
Days
Class 2
Risk

K063527 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 July 30, 2007 after a review of 250 days - an extended review cycle.

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 - K063527

510(k) Number K063527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date July 30, 2007
Days to Decision 250 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
128d slower than avg
Panel avg: 122d · This submission: 250d
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 K063527.
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K072384 · Kensey Nash Corp. · Sep 2007
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K072184 · Orthovita, Inc. · Sep 2007
BONEMEDIK, AND BONEMEDIK-S
K070897 · Meta Biomed Co., Ltd. · Sep 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630 · Etex Corp. · Jun 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237 · Kensey Nash Corp. · Jun 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007