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
Jan 09, 2003
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
Berkeley Advanced Biomaterials, Inc.
Orthopedic
155d
Cleared
Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
Synthes (Usa)
Orthopedic
29d
Cleared
Nov 26, 2002
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
Synthes
Orthopedic
439d
Cleared
Nov 05, 2002
WMT-TCP BONE GRAFT SUBSTITUTE
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
Biocomposites, Ltd.
Orthopedic
172d
Cleared
Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
Biomet, Inc.
Orthopedic
477d
Cleared
Jul 25, 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
Novabone Products, LLC
Orthopedic
90d
Cleared
Jul 22, 2002
MASTERGRAFT RESORBABLE CERAMIC
Medtronic Sofamor Danek, Inc.
Orthopedic
117d
Cleared
Jun 11, 2002
CALCIGEN-S BONE VOID FILER
Biomet Orthopedics, Inc.
Orthopedic
209d
Cleared
May 23, 2002
APATIGHT HA-BONE GRAFT SUBSTITUTE
Cerabio, LLC
Orthopedic
171d
Cleared
May 16, 2002
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
Millenium Biologix, Inc.
Orthopedic
346d
Cleared
May 16, 2002
APATIGHT-TCP BONE GRAFT SUBSTITUTE
Cerabio, LLC
Orthopedic
164d
Cleared
Mar 18, 2002
CERASORB ORTHO
Curasan AG
Orthopedic
89d
Cleared
Mar 08, 2002
CONDUIT TCP GRANULES
Depuyacromed
Orthopedic
88d
Cleared
Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
Medtronic Sofamor Danek USA, Inc.
Orthopedic
213d
Cleared
Dec 20, 2001
NORIAN SRS BONE VOID FILLER
Synthes (Usa)
Orthopedic
185d
Cleared
Nov 14, 2001
HEALOS BONE GRAFT MATERIAL
Orquest, Inc.
Orthopedic
90d
Cleared
Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
DePuy Orthopaedics, Inc.
Orthopedic
221d
Cleared
Oct 26, 2001
OSTEOSET BVF KIT
Wrightmedicaltechnologyinc
Orthopedic
245d
Cleared
Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
Neucoll, Inc.
Orthopedic
611d
Cleared
Aug 03, 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
Ebi, L.P.
Orthopedic
88d
Cleared
Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
Interpore Cross Intl.
Orthopedic
206d
Cleared
Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
Biocomposites, Ltd.
Orthopedic
203d
Cleared
May 25, 2001
JAX GRANULES BONE VOID FILLER
Smith & Nephew, Inc.
Orthopedic
88d