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
Cleared
Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
Exactech, Inc.
Orthopedic
779d
Cleared
Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
Orthovita, Inc.
Orthopedic
148d
Cleared
Dec 11, 2003
MBCP
Biomatlante
Orthopedic
141d
Cleared
Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
Etex Corp.
Orthopedic
63d
Cleared
Nov 28, 2003
TRIHA +
Teknimed, S.A.
Orthopedic
168d
Cleared
Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
Biomet Orthopedics, Inc.
Orthopedic
119d
Cleared
Nov 05, 2003
VITOSS-FILLED CARTRIDGE
Orthovita, Inc.
Orthopedic
117d
Cleared
Oct 30, 2003
PROFUSION BONE VOID FILLER KIT
Biogeneration
Orthopedic
136d
Cleared
Aug 29, 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
Orthovita, Inc.
Orthopedic
25d
Cleared
Aug 13, 2003
MODIFICATION TO CERASORB ORTHO
Curasan AG
Orthopedic
77d
Cleared
Aug 04, 2003
BONESOURCE BVF
Howmedica Osteonics
Orthopedic
90d
Cleared
Jul 24, 2003
THERIFIL BONE FILLER
Therics, Inc.
Orthopedic
114d
Cleared
Jul 17, 2003
POLYGRAFT BONE GRAFT SUBSTITUTE
Osteobiologics, Inc.
Orthopedic
170d
Cleared
Jul 17, 2003
OSTEO-G BONE VOID FILLER SYSTEM
Aspine USA, Inc.
Orthopedic
83d
Cleared
Jul 17, 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
Wrightmedicaltechnologyinc
Orthopedic
35d
Cleared
May 20, 2003
OSSATURA BCP BONE VOID FILLER
Isotis NV
Orthopedic
126d
Cleared
May 20, 2003
CALLOS
Skeletal Kinetics, LLC
Orthopedic
88d
Cleared
Apr 22, 2003
MASTERGRAFT MATRIX
Medtronic Sofamor Danek, Inc.
Orthopedic
181d
Cleared
Mar 04, 2003
MIIG II BONE GRAFT SUBSTITUTE
Wrightmedicaltechnologyinc
Orthopedic
67d
Cleared
Feb 26, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
Biomet, Inc.
Orthopedic
40d
Cleared
Feb 25, 2003
JAX
Smith & Nephew, Inc.
Orthopedic
729d
Cleared
Feb 20, 2003
CEM-OSTETIC BONE
Berkeley Advanced Biomaterials, Inc.
Orthopedic
24d
Cleared
Jan 30, 2003
BI-OSTETIC
Berkeley Advanced Biomaterials, Inc.
Orthopedic
87d
Cleared
Jan 28, 2003
BIOSORB RESORBABLE VOID FILLER
Sciences ET Bio Materiaux (Sbm)
Orthopedic
228d