Cleared Traditional

K231716 - OsteoFlo® HydroPutty™

K231716 is an FDA 510(k) clearance for OsteoFlo HydroPutty, manufactured by SurGenTec, LLC. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K231716

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.

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 398
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