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
May 03, 2005
MODIFICATION TO MBCP
Biomatlante
Orthopedic
183d
Cleared
Apr 21, 2005
CAMCERAM TCP
Cam Implants B.V.
Orthopedic
66d
Cleared
Apr 11, 2005
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
Medicrea
Orthopedic
45d
Cleared
Apr 11, 2005
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES
Berkeley Advanced Biomaterials, Inc.
Orthopedic
28d
Cleared
Mar 29, 2005
OSSAPLAST ORTHO
Ossacur AG
Orthopedic
39d
Cleared
Mar 25, 2005
DYNAGRAFT II
Isotis Orthobiologics, Inc.
Orthopedic
401d
Cleared
Mar 17, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
Musculoskeletal Transplant Foundation
Orthopedic
407d
Cleared
Feb 18, 2005
INTERGRO DBM
Interpore Cross Intl.
Orthopedic
655d
Cleared
Feb 16, 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
Depuy Spine, Inc.
Orthopedic
77d
Cleared
Feb 16, 2005
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
Regeneration Technologies, Inc.
Orthopedic
65d
Cleared
Feb 10, 2005
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
Regeneration Technologies, Inc.
Orthopedic
59d
Cleared
Feb 03, 2005
NANOSS BONE VOID FILLER
Angstrom Medica, Inc.
Orthopedic
28d
Cleared
Jan 21, 2005
ALLOGRAN-N-BONE VOID FILLER
Biocomposites, Ltd.
Orthopedic
32d
Cleared
Jan 07, 2005
SYNTHES (USA) CHRONOS
Synthes (Usa)
Orthopedic
64d
Cleared
Jan 07, 2005
BF+
Ldr Spine USA
Orthopedic
32d
Cleared
Dec 27, 2004
CEMENTEK LV
Teknimed, S.A.
Orthopedic
67d
Cleared
Dec 17, 2004
POLYGRAFT BGS
Osteobiologics, Inc.
Orthopedic
340d
Cleared
Dec 14, 2004
BIOPLUS
Berkeley Advanced Biomaterials, Inc.
Orthopedic
78d
Cleared
Nov 24, 2004
KASIOS TCP
Kasios Biomaterials
Orthopedic
86d
Cleared
Oct 21, 2004
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
Ossacur AG
Orthopedic
57d
Cleared
Sep 16, 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Aug 31, 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
Biomet Manufacturing, Inc.
Orthopedic
127d
Cleared
Aug 26, 2004
NAME BONE VOID FILLER
Stryker Biotech
Orthopedic
90d
Cleared
Aug 25, 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
Novabone Products, LLC
Orthopedic
71d