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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K063527.
INQU
K071428 · Isto Technologies, Inc. · Sep 2007
TRIBONE 80
K071121 · Biomatlante · Sep 2007
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
K061880 · Isotis NV · Aug 2007
TRIPORE, MODELS HA, BP90, BP15
K070132 · Orthogem Limited · Jul 2007
ATLANTIK
K070794 · Medical Biomat · Jul 2007
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
K071155 · Science For Biomaterials · Jul 2007
K063527 · MBCP+
Download PDF FDA Summary Biomatlante