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
337–360 of 492
Cleared Feb 03, 2005
NANOSS BONE VOID FILLER
K050025
Angstrom Medica, Inc.
Orthopedic · 28d
Cleared Jan 21, 2005
ALLOGRAN-N-BONE VOID FILLER
K043514
Biocomposites, Ltd.
Orthopedic · 32d
Cleared Jan 07, 2005
SYNTHES (USA) CHRONOS
K043045
Synthes (Usa)
Orthopedic · 64d
Cleared Jan 07, 2005
BF+
K043347
Ldr Spine USA
Orthopedic · 32d
Cleared Dec 27, 2004
CEMENTEK LV
K042911
Teknimed, S.A.
Orthopedic · 67d
Cleared Dec 14, 2004
BIOPLUS
K042636
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 78d
Cleared Nov 24, 2004
KASIOS TCP
K042340
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
K042305
Ossacur AG
Orthopedic · 57d
Cleared Sep 16, 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Aug 31, 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089
Biomet Manufacturing, Inc.
Orthopedic · 127d
Cleared Aug 26, 2004
NAME BONE VOID FILLER
K041421
Stryker Biotech
Orthopedic · 90d
Cleared Aug 25, 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613
Novabone Products, LLC
Orthopedic · 71d
Cleared Aug 25, 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
K041616
Orthos (Uk) Limited
Orthopedic · 71d
Cleared Aug 19, 2004
CEMENTEK
K041493
Teknimed, S.A.
Orthopedic · 76d
Cleared Aug 19, 2004
TRI-OSTETIC
K041889
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 38d
Cleared Aug 02, 2004
ALLOMATRIX PUTTY
K041168
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 23, 2004
NORIAN SRS FAST SET PUTTY
K041842
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
K040980
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jun 17, 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755
Exactech, Inc.
Orthopedic · 85d
Cleared Jun 10, 2004
JAX-TCP
K033552
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
K040381
Arthrex, Inc.
Orthopedic · 85d
Cleared May 07, 2004
GENEX BONE GRAFT SUBSTITUTE
K040600
Biocomposites, Ltd.
Orthopedic · 60d
Cleared May 03, 2004
EOVIA CALCIUM PHOSPHATE CERAMIC
K040514
Ortho Tec, LLC
Orthopedic · 66d
Cleared Apr 27, 2004
CALCIGEN -NAP BONE VOID FILLER
K033611
Biomet, Inc.
Orthopedic · 162d