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
Sep 11, 2008
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
Apatech , Ltd.
Orthopedic
50d
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
Cleared
Jul 22, 2008
PLEXUR M
Osteotech, Inc.
Orthopedic
83d
Cleared
Jul 09, 2008
GENEX PUTTY
Biocomposites, Ltd.
Orthopedic
224d
Cleared
Jun 20, 2008
CERAMENT BONE VOID FILLER, MODEL A0210
Bonesupport AB
Orthopedic
207d
Cleared
Jun 17, 2008
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
Orthovita, Inc.
Orthopedic
26d
Cleared
May 06, 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
Novabone Products, LLC
Orthopedic
124d
Cleared
May 02, 2008
OSFERION
Olympus Terumo Biomaterials Corporation
Orthopedic
113d
Cleared
Apr 21, 2008
PLEXUR-P
Osteotech, Inc.
Orthopedic
56d
Cleared
Apr 16, 2008
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
Apatech , Ltd.
Orthopedic
30d
Cleared
Apr 15, 2008
COMPORUS
Takiron Co., Ltd.
Orthopedic
582d
Cleared
Apr 04, 2008
WELLGRAFT PE II
Gwowei Technology Co., Ltd.
Orthopedic
242d
Cleared
Apr 04, 2008
WELLGRAFT PE I
Gwowei Technology Co., Ltd.
Orthopedic
242d
Cleared
Mar 11, 2008
GRAFTYS BCP
Graftys
Orthopedic
133d
Cleared
Mar 10, 2008
MERRIES K-PHATE BONE GRAFT SUBSTITUTE
Merries International, Inc.
Orthopedic
510d
Cleared
Mar 03, 2008
PLEXUR M
Osteotech, Inc.
Orthopedic
90d
Cleared
Feb 01, 2008
BONALIVE GRANULES
Vivoxid , Ltd.
Orthopedic
277d
Cleared
Jan 25, 2008
BIOSET XCH
Regeneration Technologies, Inc.
Orthopedic
165d
Cleared
Jan 09, 2008
PROGENIX DMB PUTTY
Medtronic Sofamor Danek
Orthopedic
147d
Cleared
Dec 20, 2007
MICROFUSE BONE VOID FILLER
Globus Medical, Inc.
Orthopedic
234d
Cleared
Dec 17, 2007
CROSS.BONE
TriMed, Inc.
Orthopedic
164d
Cleared
Nov 19, 2007
CAP PLUS
Etex Corp.
Orthopedic
411d
Cleared
Nov 09, 2007
POLYGRAFT BGS
Smith & Nephew, Inc.
Orthopedic
430d