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, Novabone Products, LLC and Berkeley Advanced Biomaterials, Inc..

493
Total
493
Cleared
149d
Avg days
1996
Since
493 devices
433–456 of 493
Cleared Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
K020078
Exactech, Inc.
Orthopedic · 779d
Cleared Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288
Orthovita, Inc.
Orthopedic · 148d
Cleared Dec 11, 2003
MBCP
K032268
Biomatlante
Orthopedic · 141d
Cleared Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138
Etex Corp.
Orthopedic · 63d
Cleared Nov 28, 2003
TRIHA +
K031826
Teknimed, S.A.
Orthopedic · 168d
Cleared Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286
Biomet Orthopedics, Inc.
Orthopedic · 119d
Cleared Nov 05, 2003
VITOSS-FILLED CARTRIDGE
K032130
Orthovita, Inc.
Orthopedic · 117d
Cleared Oct 30, 2003
PROFUSION BONE VOID FILLER KIT
K031838
Biogeneration
Orthopedic · 136d
Cleared Aug 29, 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409
Orthovita, Inc.
Orthopedic · 25d
Cleared Aug 13, 2003
MODIFICATION TO CERASORB ORTHO
K031651
Curasan AG
Orthopedic · 77d
Cleared Aug 04, 2003
BONESOURCE BVF
K031435
Howmedica Osteonics
Orthopedic · 90d
Cleared Jul 24, 2003
THERIFIL BONE FILLER
K031040
Therics, Inc.
Orthopedic · 114d
Cleared Jul 17, 2003
POLYGRAFT BONE GRAFT SUBSTITUTE
K030288
Osteobiologics, Inc.
Orthopedic · 170d
Cleared Jul 17, 2003
OSTEO-G BONE VOID FILLER SYSTEM
K031319
Aspine USA, Inc.
Orthopedic · 83d
Cleared Jul 17, 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared May 20, 2003
OSSATURA BCP BONE VOID FILLER
K030131
Isotis NV
Orthopedic · 126d
Cleared May 20, 2003
CALLOS
K030554
Skeletal Kinetics, LLC
Orthopedic · 88d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Mar 04, 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Feb 26, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178
Biomet, Inc.
Orthopedic · 40d
Cleared Feb 25, 2003
JAX
K010555
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Feb 20, 2003
CEM-OSTETIC BONE
K030266
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 24d
Cleared Jan 30, 2003
BI-OSTETIC
K023703
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 87d
Cleared Jan 28, 2003
BIOSORB RESORBABLE VOID FILLER
K021963
Sciences ET Bio Materiaux (Sbm)
Orthopedic · 228d