MQV · Class II · 21 CFR 888.3045

FDA Product Code MQV: Filler, Bone Void, Calcium Compound

Under FDA product code MQV, calcium compound bone void fillers are cleared for use in orthopedic and spinal surgery.

These synthetic graft materials — including calcium phosphate, calcium sulfate, and hydroxyapatite formulations — are used to fill bone defects created by trauma, tumor resection, or surgical procedures. They resorb over time as new bone grows to replace them.

MQV devices are Class II medical devices, regulated under 21 CFR 888.3045 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Orthocon, Inc., SeaSpine Orthopedics Corporation and SurGenTec, LLC.

31
Total
31
Cleared
90d
Avg days
2022
Since

List of Filler, Bone Void, Calcium Compound devices cleared through 510(k)

31 devices
1–24 of 31
Cleared Jul 17, 2025
Device 300423 Granules
K251556
Geistlich Pharma AG
Orthopedic · 57d
Cleared Jul 02, 2025
OsteoFlo HydroFiber
K251720
SurGenTec, LLC
Orthopedic · 28d
Cleared Jun 12, 2025
Grafton™ DBM
K251193
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared May 28, 2025
OsteoFlo HydroFiber
K243949
SurGenTec, LLC
Orthopedic · 156d
Cleared Apr 07, 2025
NanoBone® SBX Putty
K250521
Biocomposites, Ltd.
Orthopedic · 45d
Cleared Jan 17, 2025
Mastergraft Matrix EXT
K243706
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Dec 23, 2024
OsteoFlo HydroFiber
K242797
SurGenTec, LLC
Orthopedic · 98d
Cleared Dec 05, 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.
Orthopedic · 21d
Cleared Nov 18, 2024
Montage-XT Settable Bone Putty
K243506
Orthocon, Inc.
Orthopedic · 6d
Cleared Nov 08, 2024
Device 300397 Putty
K241802
Geistlich Pharma AG
Orthopedic · 140d
Cleared Sep 25, 2024
Cove Putty, OsteoCove Putty
K242273
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared Sep 25, 2024
NovaBone Putty - Synthetic Bioactive Bone Graft
K242299
Novabone Products, LLC
Orthopedic · 54d
Cleared Aug 29, 2024
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
K242280
Stryker Spine
Orthopedic · 27d
Cleared Aug 21, 2024
Montage-XT Settable, Resorbable Bone Putty
K233566
Orthocon, Inc.
Orthopedic · 289d
Cleared Aug 02, 2024
Actifuse ABX
K241564
Baxter Healthcare Corporation
Orthopedic · 63d
Cleared Jul 29, 2024
Montage Settable Bone Putty
K242050
Orthocon, Inc.
Orthopedic · 17d
Cleared Mar 20, 2024
NuVasive AttraX Scaffold
K240507
Nuvasive, Inc.
Orthopedic · 28d
Cleared Mar 12, 2024
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
K240424
Collagen Matrix, Inc.
Orthopedic · 28d
Cleared Mar 05, 2024
NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
K240404
Novabone Products, LLC
Orthopedic · 25d
Cleared Oct 02, 2023
OsteoFlo® HydroPutty™
K231716
SurGenTec, LLC
Orthopedic · 111d
Cleared Sep 27, 2023
Cove Strip, OsteoCove Strip
K232668
SeaSpine Orthopedics Corporation
Orthopedic · 26d
Cleared Sep 14, 2023
Cove Putty, OsteoCove Putty
K231030
SeaSpine Orthopedics Corporation
Orthopedic · 156d
Cleared Sep 01, 2023
Montage Flowable Settable, Resorbable Bone Paste
K231270
Orthocon, Inc.
Orthopedic · 122d
Cleared Aug 25, 2023
Montage-QS Settable, Resorbable Bone Putty
K231903
Orthocon, Inc.
Orthopedic · 58d

How to use this database

This page lists all FDA 510(k) submissions for Filler, Bone Void, Calcium Compound devices (product code MQV). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →