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 Kuros Biosciences B.V.
492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
Cleared
Apr 18, 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
Medtronic Sofamor Danek USA, Inc.
Orthopedic
63d
Cleared
Apr 08, 2014
ULTRAFUSE
Baxter Healthcare Corp
Orthopedic
403d
Cleared
Mar 24, 2014
PRODENSE BONE GRAFT SUBSTITUTE
Wrightmedicaltechnologyinc
Orthopedic
210d
Cleared
Mar 14, 2014
BG MORSELS
Prosidyan, Inc.
Orthopedic
189d
Cleared
Feb 07, 2014
NB3D BONE VOID FILLER
Pioneer Surgical Technology, Inc.
Orthopedic
220d
Cleared
Jan 10, 2014
BIOACTIVE BONE GRAFT PUTTY
Biostructures, LLC
Orthopedic
191d
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
Aug 12, 2013
VIVORTE BVF LITE
Vivorte, Inc.
Orthopedic
111d
Cleared
Jul 15, 2013
NEOTIS
Sbm Sciences For Bio Materials
Orthopedic
101d
Cleared
Apr 19, 2013
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY
Synergy Biomedical, LLC
Orthopedic
213d
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
Mar 21, 2013
BETA-TCP GRANULES
Skeletal Kinetics, LLC
Orthopedic
409d
Cleared
Feb 05, 2013
A-GRIX TE RESORABLE BONE VOID FILLER
Ag Digital Technology Corp.
Orthopedic
265d
Cleared
Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
Medtronic Sofamor Danek, Inc.
Orthopedic
59d
Cleared
Jan 11, 2013
MTF NEW BONE VOID FILLER
Musculoskeletal Transplant Foundation
Orthopedic
254d
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
Sep 18, 2012
BICERA (TM) RESORBABLE BONE SUBSTITUTE
Wiltrom Corporation Limited
Orthopedic
533d
Cleared
May 04, 2012
KENSEY NASH BONE VOID FILLER XC
Kensey Nash Cororation
Orthopedic
107d
Cleared
Apr 06, 2012
NANOFUSE DBM
Nanotherapeutics
Orthopedic
67d
Cleared
Mar 23, 2012
APACERAM BONE GRAFT SUBSTITUTE
Hoya Corporation
Orthopedic
24d
Cleared
Mar 15, 2012
B-GENIN, R-GENIN
Berkeley Advanced Biomaterials, Inc.
Orthopedic
84d