Cleared Traditional

Porous Biologic Scaffold (K240765) - FDA 510(k) Clearance

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

K240765 · Ventris Medical · Orthopedic device
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Dec 2024
Decision
273d
Days
Class 2
Risk

K240765 is an FDA 510(k) clearance for the Porous Biologic Scaffold. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ventris Medical (Newport Beach, US). The FDA issued a Cleared decision on December 18, 2024 after a review of 273 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 Ventris Medical devices

Submission Details

510(k) Number K240765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2024
Decision Date December 18, 2024
Days to Decision 273 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
151d slower than avg
Panel avg: 122d · This submission: 273d
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 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K240765.
GlassBone Granules
K242782 · Noraker · Dec 2024
OsteoFlo HydroFiber
K242797 · SurGenTec, LLC · Dec 2024
BioSphere Putty
K241167 · Synergy Biomedical · Dec 2024
EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
K243609 · Etex Corporation · Dec 2024
MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
K243526 · Orthocon, Inc. · Dec 2024
Montage-XT Settable Bone Putty
K243506 · Orthocon, Inc. · Nov 2024