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, Novabone Products, LLC and Orthovita, Inc..

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
361–384 of 492
Cleared Apr 02, 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828
Wrightmedicaltechnologyinc
Orthopedic · 585d
Cleared Mar 05, 2004
ALLOMATRIX MODEL# 86
K020895
Wrightmedicaltechnologyinc
Orthopedic · 717d
Cleared Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
K020078
Exactech, Inc.
Orthopedic · 779d
Cleared Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288
Orthovita, Inc.
Orthopedic · 148d
Cleared Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138
Etex Corp.
Orthopedic · 63d
Cleared Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286
Biomet Orthopedics, Inc.
Orthopedic · 119d
Cleared Nov 05, 2003
VITOSS-FILLED CARTRIDGE
K032130
Orthovita, Inc.
Orthopedic · 117d
Cleared Aug 29, 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409
Orthovita, Inc.
Orthopedic · 25d
Cleared Jul 17, 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Mar 04, 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Feb 26, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178
Biomet, Inc.
Orthopedic · 40d
Cleared Feb 25, 2003
JAX
K010555
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862
Synthes (Usa)
Orthopedic · 29d
Cleared Nov 05, 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551
Biocomposites, Ltd.
Orthopedic · 172d
Cleared Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531
Biomet, Inc.
Orthopedic · 477d
Cleared Jul 25, 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336
Novabone Products, LLC
Orthopedic · 90d
Cleared Jul 22, 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986
Medtronic Sofamor Danek, Inc.
Orthopedic · 117d
Cleared Jun 11, 2002
CALCIGEN-S BONE VOID FILER
K013790
Biomet Orthopedics, Inc.
Orthopedic · 209d
Cleared Mar 08, 2002
CONDUIT TCP GRANULES
K014053
Depuyacromed
Orthopedic · 88d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897
Synthes (Usa)
Orthopedic · 185d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048
DePuy Orthopaedics, Inc.
Orthopedic · 221d