Cleared Traditional

K231716 - OsteoFlo HydroPutty

K231716 is the FDA 510(k) clearance for OsteoFlo HydroPutty by SurGenTec, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K231716 · SurGenTec, LLC · Orthopedic device
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Oct 2023
Decision
111d
Days
Class 2
Risk

K231716 is an FDA 510(k) clearance for the OsteoFlo® HydroPutty™. 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 October 2, 2023 after a review of 111 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 SurGenTec, LLC devices

Submission Details

510(k) Number K231716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2023
Decision Date October 02, 2023
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 231
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K231716.
MagnetOs Easypack Putty
K233607 · Kuros Biosciences B.V · Dec 2023
SIGNAFUSE Bioactive Strip (SBS)
K233490 · Bioventus, LLC · Dec 2023
MagnetOs Flex Matrix
K233245 · Kuros Biosciences B.V · Nov 2023
Cove Strip, OsteoCove Strip
K232668 · SeaSpine Orthopedics Corporation · Sep 2023
Catalyst Bone Void Filler
K232315 · Ossdsign AB · Sep 2023
Cove Putty, OsteoCove Putty
K231030 · SeaSpine Orthopedics Corporation · Sep 2023