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
Jun 12, 2009
E-MATRIX GRAFT BONE EXTENDER
Pioneer Surgical Technology
Orthopedic
203d
Cleared
Jun 02, 2009
MASTERGRAFT STRIP
Medtronic Sofamor Danek
Orthopedic
306d
Cleared
May 27, 2009
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1
Intra-Lock International, Inc.
Orthopedic
278d
Cleared
May 21, 2009
OSTEOCRETE BONE VOID FILLER
Bone Solutions, Inc.
Orthopedic
773d
Cleared
Apr 15, 2009
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
Novabone Products, LLC
Orthopedic
27d
Cleared
Apr 02, 2009
INTERGRO DBM
Biomet Spine
Orthopedic
191d
Cleared
Mar 24, 2009
EQUIVABONE
Etex Corp.
Orthopedic
46d
Cleared
Feb 25, 2009
GRAFTYS HBS
Graftys
Orthopedic
180d
Cleared
Feb 20, 2009
INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE
Inion OY
Orthopedic
28d
Cleared
Feb 20, 2009
GAMMA-BSM, BETA-BSM
Etex Corp.
Orthopedic
18d
Cleared
Feb 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
Medtronic Sofamor Danek
Orthopedic
132d
Cleared
Jan 28, 2009
CALTRIX RESORBABLE BONE VOID FILLER
Ag Digital Technology Corp.
Orthopedic
82d
Cleared
Dec 24, 2008
MODIFICATION TO:MICROFUSE BONE VOID FILLER
Globus Medical, Inc.
Orthopedic
51d
Cleared
Dec 09, 2008
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
Novabone Products, LLC
Orthopedic
85d
Cleared
Dec 04, 2008
ALLOFUSE GEL AND PUTTY
Allosource, Inc.
Orthopedic
518d
Cleared
Nov 25, 2008
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
Apatech , Ltd.
Orthopedic
81d
Cleared
Nov 24, 2008
PROGENIX PLUS
Medtronic Sofamor Danek
Orthopedic
133d
Cleared
Nov 14, 2008
GENEX
Biocomposites, Ltd.
Orthopedic
87d
Cleared
Nov 06, 2008
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
Apatech , Ltd.
Orthopedic
118d
Cleared
Nov 06, 2008
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
Orthovita, Inc.
Orthopedic
27d
Cleared
Oct 16, 2008
POLYBONE GRANULE & BLOCK
Kyung Won Medical Co., Ltd.
Orthopedic
63d
Cleared
Oct 16, 2008
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
Osteotech, Inc.
Orthopedic
37d
Cleared
Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
Baxter Healthcare Corp
Orthopedic
114d
Cleared
Oct 07, 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
Globus Medical, Inc.
Orthopedic
43d