Cleared Traditional

K162860 - MCS Bone Graft

K162860 is an FDA 510(k) clearance for MCS Bone Graft, manufactured by Bioventus, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K162860 · Bioventus, LLC · Orthopedic device
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Feb 2017
Decision
124d
Days
Class 2
Risk

K162860 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 Bioventus, LLC (Durham, US). The FDA issued a Cleared decision on February 13, 2017 after a review of 124 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 Bioventus, LLC devices

FDA 510(k) Submission Details - K162860

510(k) Number K162860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2016
Decision Date February 13, 2017
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 291
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K162860.
NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
Resorbable Mesh Device
K172130 · SeaSpine Orthopedics Corporation · Nov 2017
Vitoss Bioactive (BA) Injectable
K163621 · Orthovita, Inc. · May 2017
NovaBone IRM
K163310 · Novabone Products, LLC · Jan 2017
HydroSet XT
K161447 · Orthovita, Inc. · Oct 2016
Vitoss BiModal Bone Graft Substitute Foam Strip
K153608 · Orthovita, Inc. · Feb 2016