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
385–408 of 492
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 Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954
Biocomposites, Ltd.
Orthopedic · 203d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Dec 14, 2000
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K994337
Orthovita Co.
Orthopedic · 357d
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 Aug 04, 2000
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
K001724
Biocomposites, Ltd.
Orthopedic · 59d
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 Sep 25, 1998
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
K980817
Interpore Intl.
Orthopedic · 206d
Cleared Apr 03, 1998
PROFUSION BONE VOID FILLER
K973704
Biogeneration
Orthopedic · 186d
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