MQV · Class II · 21 CFR 888.3045

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
145–168 of 492
Cleared Dec 24, 2013
SIGNIFY BIOACTIVE
K130977
Globus Medical, Inc.
Orthopedic · 259d
Cleared Oct 03, 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Aug 15, 2013
KINEX BIOACTIVE
K130392
Globus Medical, Inc.
Orthopedic · 181d
Cleared Apr 19, 2013
MASTERGRAFT STRIP
K130335
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 67d
Cleared Mar 25, 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871
Wrightmedicaltechnologyinc
Orthopedic · 451d
Cleared Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691
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,
K121989
Exactech, Inc.
Orthopedic · 144d
Cleared Apr 29, 2011
FORTROSS BONE VOID FILLER
K110561
Pioneer Surgical Technology
Orthopedic · 60d
Cleared Jan 27, 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722
Synthes USA Products, LLC
Orthopedic · 128d
Cleared Dec 22, 2010
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392
Globus Medical, Inc.
Orthopedic · 121d
Cleared May 28, 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608
Collagen Matrix, Inc.
Orthopedic · 276d
Cleared Apr 22, 2010
NANOSS BONE VOID FILLER
K100361
Pioneer Surgical Technology
Orthopedic · 69d
Cleared Dec 04, 2009
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302
Integra LifeSciences Corporation
Orthopedic · 214d
Cleared Nov 17, 2009
PIONEER SURGICAL NANOSS BVF-E
K091031
Pioneer Surgical Technology
Orthopedic · 221d
Cleared Aug 27, 2009
WMT COMPOSITE DBM
K083270
Wrightmedicaltechnologyinc
Orthopedic · 294d
Cleared Jun 12, 2009
E-MATRIX GRAFT BONE EXTENDER
K083449
Pioneer Surgical Technology
Orthopedic · 203d
Cleared Jun 02, 2009
MASTERGRAFT STRIP
K082166
Medtronic Sofamor Danek
Orthopedic · 306d
Cleared Feb 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared Dec 24, 2008
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232
Globus Medical, Inc.
Orthopedic · 51d
Cleared Nov 24, 2008
PROGENIX PLUS
K082002
Medtronic Sofamor Danek
Orthopedic · 133d
Cleared Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717
Baxter Healthcare Corp
Orthopedic · 114d
Cleared Oct 07, 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442
Globus Medical, Inc.
Orthopedic · 43d
Cleared Sep 03, 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
K081758
Depuy Spine, Inc.
Orthopedic · 75d
Cleared Aug 25, 2008
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
K081558
Pioneer Surgical Technology
Orthopedic · 83d