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
217–240 of 492
Cleared Mar 08, 2002
CONDUIT TCP GRANULES
K014053
Depuyacromed
Orthopedic · 88d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897
Synthes (Usa)
Orthopedic · 185d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048
DePuy Orthopaedics, Inc.
Orthopedic · 221d
Cleared Oct 26, 2001
OSTEOSET BVF KIT
K010532
Wrightmedicaltechnologyinc
Orthopedic · 245d
Cleared Aug 03, 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
K011386
Ebi, L.P.
Orthopedic · 88d
Cleared Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
K004003
Interpore Cross Intl.
Orthopedic · 206d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Nov 01, 2000
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
K002362
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 15, 2000
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
K000515
Interpore Cross Intl.
Orthopedic · 212d
Cleared Jun 20, 2000
CALCIUM SULFATE PELLETS
K001559
Howmedica Osteonics Corp.
Orthopedic · 32d
Cleared Aug 26, 1999
OSTEOPLAST, MODEL POP200
K991854
Interpore Cross Intl.
Orthopedic · 86d
Cleared Mar 02, 1999
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
K990131
Interpore Cross Intl.
Orthopedic · 47d
Cleared Feb 26, 1999
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
K982663
Encore Orthopedics, Inc.
Orthopedic · 211d
Cleared May 07, 1997
WRIGHT PLASTER OF PARIS PELLETS
K963562
Wrightmedicaltechnologyinc
Orthopedic · 244d
Cleared Mar 24, 1997
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)
K963587
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Jun 21, 1996
WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)
K960978
Wrightmedicaltechnologyinc
Orthopedic · 102d