Cleared Traditional

NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT (K141600) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141600 · Pioneer Surgical Technology, Inc. (Rti Surgical, I · Orthopedic device
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Oct 2014
Decision
123d
Days
Class 2
Risk

K141600 is an FDA 510(k) clearance for the NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Rti Surgical, I (Marquette, US). The FDA issued a Cleared decision on October 17, 2014 after a review of 123 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 Pioneer Surgical Technology, Inc. (Rti Surgical, I devices

Submission Details

510(k) Number K141600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date October 17, 2014
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 195
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K141600.
BioSphere MIS Putty (BioSphere MIS)
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NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
MASTERGRAFT Contain
K151172 · Medtronic Sofamor Danek USA, Inc. · Aug 2015
CONFIRM BIOACTIVE
K133678 · Globus Medical, Inc. · Aug 2014
AS20 COMPOSITE GRAFT
K141746 · Wrightmedicaltechnologyinc · Aug 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375 · Medtronic Sofamor Danek USA, Inc. · Apr 2014