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, Kuros Biosciences B.V and Synthes (Usa).

492
Total
492
Cleared
149d
Avg days
1996
Since
492 devices
193–216 of 492
Cleared Feb 16, 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308
Depuy Spine, Inc.
Orthopedic · 77d
Cleared Jan 07, 2005
SYNTHES (USA) CHRONOS
K043045
Synthes (Usa)
Orthopedic · 64d
Cleared Sep 16, 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663
Wrightmedicaltechnologyinc
Orthopedic · 90d
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 Apr 27, 2004
CALCIGEN -NAP BONE VOID FILLER
K033611
Biomet, Inc.
Orthopedic · 162d
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 Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286
Biomet Orthopedics, Inc.
Orthopedic · 119d
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 Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531
Biomet, Inc.
Orthopedic · 477d
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