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
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 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
Cleared
Aug 25, 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
Orthos (Uk) Limited
Orthopedic
71d
Cleared
Aug 19, 2004
CEMENTEK
Teknimed, S.A.
Orthopedic
76d
Cleared
Aug 19, 2004
TRI-OSTETIC
Berkeley Advanced Biomaterials, Inc.
Orthopedic
38d
Cleared
Aug 02, 2004
ALLOMATRIX PUTTY
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Jul 23, 2004
NORIAN SRS FAST SET PUTTY
Synthes (Usa)
Orthopedic
15d
Cleared
Jul 14, 2004
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Jun 17, 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
Exactech, Inc.
Orthopedic
85d
Cleared
Jun 10, 2004
JAX-TCP
Smith & Nephew, Inc.
Orthopedic
211d
Cleared
May 12, 2004
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
Arthrex, Inc.
Orthopedic
85d
Cleared
May 07, 2004
GENEX BONE GRAFT SUBSTITUTE
Biocomposites, Ltd.
Orthopedic
60d
Cleared
May 03, 2004
EOVIA CALCIUM PHOSPHATE CERAMIC
Ortho Tec, LLC
Orthopedic
66d
Cleared
Apr 27, 2004
CALCIGEN -NAP BONE VOID FILLER
Biomet, Inc.
Orthopedic
162d