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
Nov 09, 2007
MASTERGRAFT PUTTY
Medtronic Sofamor Danek
Orthopedic
130d
Cleared
Oct 29, 2007
APACERAM BONE GRAFT SUBSTITUTE
Pentax Corp.
Orthopedic
110d
Cleared
Oct 24, 2007
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
Regeneration Technologies, Inc.
Orthopedic
65d
Cleared
Oct 23, 2007
SYNTHES CHRONOS COMPOSITE
Synthes (Usa)
Orthopedic
193d
Cleared
Oct 23, 2007
A-BSM BONE SUBSTITUTE MATERIAL
Etex Corp.
Orthopedic
35d
Cleared
Oct 15, 2007
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
Isotis Orthobiologics, Inc.
Orthopedic
210d
Cleared
Oct 15, 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
Wrightmedicaltechnologyinc
Orthopedic
31d
Cleared
Oct 11, 2007
INION BIORESTORE
Inion OY
Orthopedic
185d
Cleared
Sep 26, 2007
OSSIFUSE BONE SUBSTITUTE MATERIAL
Etex Corp.
Orthopedic
35d
Cleared
Sep 21, 2007
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
Kensey Nash Corp.
Orthopedic
28d
Cleared
Sep 18, 2007
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
Orthovita, Inc.
Orthopedic
43d
Cleared
Sep 17, 2007
BONEMEDIK, AND BONEMEDIK-S
Meta Biomed Co., Ltd.
Orthopedic
168d
Cleared
Sep 17, 2007
INQU
Isto Technologies, Inc.
Orthopedic
117d
Cleared
Sep 11, 2007
TRIBONE 80
Biomatlante
Orthopedic
144d
Cleared
Aug 15, 2007
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
Isotis NV
Orthopedic
408d
Cleared
Jul 30, 2007
MBCP+
Biomatlante
Orthopedic
250d
Cleared
Jul 13, 2007
TRIPORE, MODELS HA, BP90, BP15
Orthogem Limited
Orthopedic
178d
Cleared
Jul 10, 2007
ATLANTIK
Medical Biomat
Orthopedic
110d
Cleared
Jul 03, 2007
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
Science For Biomaterials
Orthopedic
69d
Cleared
Jun 28, 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
Etex Corp.
Orthopedic
296d
Cleared
Jun 01, 2007
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
Biomet Osteobiologics
Orthopedic
65d
Cleared
Jun 01, 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
Kensey Nash Corp.
Orthopedic
29d
Cleared
May 31, 2007
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
Apatech , Ltd.
Orthopedic
30d
Cleared
May 09, 2007
PRO-DENSE BONE VOID FILLER
Wrightmedicaltechnologyinc
Orthopedic
83d