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
Cleared
Dec 24, 2013
SIGNIFY BIOACTIVE
Globus Medical, Inc.
Orthopedic
259d
Cleared
Oct 03, 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
Medtronic Sofamor Danek USA, Inc.
Orthopedic
118d
Cleared
Aug 15, 2013
KINEX BIOACTIVE
Globus Medical, Inc.
Orthopedic
181d
Cleared
Apr 19, 2013
MASTERGRAFT STRIP
Medtronic Sofamor Danek USA, Inc.
Orthopedic
67d
Cleared
Mar 25, 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
Wrightmedicaltechnologyinc
Orthopedic
451d
Cleared
Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
Medtronic Sofamor Danek, Inc.
Orthopedic
59d
Cleared
Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
Exactech, Inc.
Orthopedic
144d
Cleared
Apr 29, 2011
FORTROSS BONE VOID FILLER
Pioneer Surgical Technology
Orthopedic
60d
Cleared
Jan 27, 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
Synthes USA Products, LLC
Orthopedic
128d
Cleared
Dec 22, 2010
MICROFUSE PUTTY AND MICROFUSE ST MIS
Globus Medical, Inc.
Orthopedic
121d
Cleared
May 28, 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
Collagen Matrix, Inc.
Orthopedic
276d
Cleared
Apr 22, 2010
NANOSS BONE VOID FILLER
Pioneer Surgical Technology
Orthopedic
69d
Cleared
Dec 04, 2009
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
Integra LifeSciences Corporation
Orthopedic
214d
Cleared
Nov 17, 2009
PIONEER SURGICAL NANOSS BVF-E
Pioneer Surgical Technology
Orthopedic
221d
Cleared
Aug 27, 2009
WMT COMPOSITE DBM
Wrightmedicaltechnologyinc
Orthopedic
294d
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
Feb 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
Medtronic Sofamor Danek
Orthopedic
132d
Cleared
Dec 24, 2008
MODIFICATION TO:MICROFUSE BONE VOID FILLER
Globus Medical, Inc.
Orthopedic
51d
Cleared
Nov 24, 2008
PROGENIX PLUS
Medtronic Sofamor Danek
Orthopedic
133d
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
Cleared
Sep 03, 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
Depuy Spine, Inc.
Orthopedic
75d
Cleared
Aug 25, 2008
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
Pioneer Surgical Technology
Orthopedic
83d