Cleared Traditional

K200064 - OsteoFlo NanoPutty-Quadphasic Synthetic...

K200064 is the FDA 510(k) clearance for OsteoFlo NanoPutty-Quadphasic Synthetic... by SurGenTec, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K200064 · SurGenTec, LLC · Orthopedic device
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Aug 2020
Decision
214d
Days
Class 2
Risk

K200064 is an FDA 510(k) clearance for the OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on August 14, 2020 after a review of 214 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 SurGenTec, LLC devices

Submission Details

510(k) Number K200064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2020
Decision Date August 14, 2020
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
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 232
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K200064.
Uni-FuZe-P Bone Putty
K201781 · Zavation Medical Products, LLC · Dec 2020
PRO-DENSE LoVisc Bone Graft Substitute
K200507 · Wrightmedicaltechnologyinc · Oct 2020
Cerament Bone Void Filler
K201535 · Bonesupport AB · Oct 2020
CureOs TCP
K191670 · Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic · Aug 2020
Altapore MIS
K201464 · Baxter Healthcare Corporation · Jun 2020
SIGNAFUSE Bioactive Bone Graft
K193513 · Bioventus · Jun 2020