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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Trisler Consulting
Patsy J. Trisler, JD, RAC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K142276.
NANOBONE / GRANULATE
K141189 · Artoss GmbH · Jan 2015
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · Biocomposites, Ltd. · Jan 2015
NANOFUSE DBM
K142104 · Nanotherapeutics, Inc. · Jan 2015
osteoSPAN Morpheus
K142828 · Biogennix · Jan 2015
Vivorte Trabexus
K143549 · Vivorte, Inc. · Jan 2015
Bio2 CLM BG Bioactive Scaffold
K142463 · Bio2 Technologies, Inc. · Dec 2014