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
Feb 18, 2010
CARRIGEN
Etex Corp.
Orthopedic
105d
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
Nov 02, 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
Etex Corp.
Orthopedic
152d
Cleared
Sep 28, 2009
KAINOS+
Signus Medizintechnik GmbH
Orthopedic
223d
Cleared
Sep 28, 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
Musculoskeletal Transplant Foundation
Orthopedic
154d
Cleared
Sep 18, 2009
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
Etex Corp.
Orthopedic
172d
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
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 20, 2009
GAMMA-BSM, BETA-BSM
Etex Corp.
Orthopedic
18d
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
Dec 09, 2008
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
Novabone Products, LLC
Orthopedic
85d
Cleared
Nov 24, 2008
PROGENIX PLUS
Medtronic Sofamor Danek
Orthopedic
133d
Cleared
Nov 14, 2008
GENEX
Biocomposites, Ltd.
Orthopedic
87d
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
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
Cleared
Sep 03, 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
Depuy Spine, Inc.
Orthopedic
75d