Cleared Traditional

K142276 - MCS Bone Graft

K142276 is an FDA 510(k) clearance for MCS Bone Graft, manufactured by Biostructures, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K142276 · Biostructures, LLC · Orthopedic device
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Jan 2015
Decision
154d
Days
Class 2
Risk

K142276 is an FDA 510(k) clearance for the MCS Bone Graft. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biostructures, LLC (Newport Beach, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 154 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 Biostructures, LLC devices

FDA 510(k) Submission Details - K142276

510(k) Number K142276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2014
Decision Date January 16, 2015
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
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 306
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K142276.
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
K152071 · Novabone Products, LLC · Aug 2015
MASTERGRAFT Contain
K151172 · Medtronic Sofamor Danek USA, Inc. · Aug 2015
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · Biocomposites, Ltd. · Jan 2015
NOVABONE BIOACTIVE STRIP
K141207 · Novabone Products, LLC · Oct 2014
MASTERGRAFT MATRIX EXT
K141824 · Medtronic Sofamor Danek, Inc. · Sep 2014
CONFIRM BIOACTIVE
K133678 · Globus Medical, Inc. · Aug 2014