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 Wrightmedicaltechnologyinc, Kuros Biosciences B.V and Synthes (Usa).

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
97–120 of 492
Cleared Feb 13, 2020
Agilon Moldable
K193168
Biogennix, LLC
Orthopedic · 90d
Cleared Jan 30, 2020
SCS 17-01
K190956
Anika Therapeutics, Inc.
Orthopedic · 294d
Cleared Jan 09, 2020
Altapore
K192363
Baxter Healthcare Corporation
Orthopedic · 132d
Cleared Nov 30, 2019
Resorbable Mesh Device
K193040
SeaSpine Orthopedics Corporation
Orthopedic · 30d
Cleared Nov 03, 2019
NuVasive AttraX Putty
K191974
Nu Vasive, Incorporated
Orthopedic · 102d
Cleared Oct 19, 2019
Altapore Shape
K191513
Baxter Healthcare Corporation
Orthopedic · 134d
Cleared Sep 27, 2019
Sorrento Bone Graft Substitute
K191074
Xenco Medical, LLC
Orthopedic · 157d
Cleared Aug 09, 2019
Morpheus-C
K190371
Biogennix, LLC
Orthopedic · 175d
Cleared Aug 07, 2019
BonAlive Granules
K191274
Bonalive Biomaterials, Ltd.
Orthopedic · 86d
Cleared Jul 31, 2019
Inion BioRestore
K191764
Inion OY
Orthopedic · 30d
Cleared Jun 23, 2019
Orthoss(R)
K190754
Geistlich Pharma AG
Orthopedic · 90d
Cleared Jun 10, 2019
AccuFill Bone Substitute Material
K190814
Zimmer Knee Creations
Orthopedic · 73d
Cleared May 28, 2019
IGNITE Bone Void Filler
K190482
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Apr 23, 2019
NanoBone SBX PUTTY, NanoBone QD
K190110
Artoss GmbH
Orthopedic · 90d
Cleared Mar 21, 2019
Mineral Collagen Composite Bioactive Moldable
K182074
Collagen Matrix, Inc.
Orthopedic · 232d
Cleared Mar 14, 2019
PROSTIM Injectable Inductive Graft
K190283
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Dec 20, 2018
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
K182670
Prosidyan, Inc.
Orthopedic · 86d
Cleared Dec 06, 2018
MagnetOs Putty
K181958
Kuros Biosciences B.V
Orthopedic · 136d
Cleared Nov 02, 2018
PRODENSE Bone Graft Substitute
K182823
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Oct 24, 2018
Osteocera Resorbable Bone Substitute
K180758
Wiltrom Corporation Limited
Orthopedic · 216d
Cleared Sep 17, 2018
Ceracell Ortho Foam
K181721
Curasan AG
Orthopedic · 80d
Cleared Sep 13, 2018
Sorrento Bioglass Bone Graft Substitute
K173933
Xenco Medical, LLC
Orthopedic · 261d
Cleared Sep 12, 2018
BioSphere Flex
K173424
Synergy Biomedical
Orthopedic · 315d
Cleared Sep 12, 2018
PRODENSE Bone Graft Substitute
K181255
Wrightmedicaltechnologyinc
Orthopedic · 124d