MBP · Class II · 21 CFR 888.3045

FDA Product Code MBP: Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

Leading manufacturers include Musculoskeletal Transplant Foundation, Osteotech, Inc. and Exactech, Inc..

31
Total
31
Cleared
179d
Avg days
2005
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 65d recently vs 183d historically

FDA 510(k) Cleared Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) Devices (Product Code MBP)

31 devices
1–24 of 31
Cleared Nov 21, 2024
PliaFX Flo
K242799
Lifenet Health
Orthopedic · 65d
Cleared Jan 14, 2015
Vivorte Trabexus EB
K143547
Vivorte, Inc.
Orthopedic · 30d
Cleared Sep 12, 2013
VIVORTE BVF
K130703
Vivorte, Inc.
Orthopedic · 181d
Cleared May 31, 2013
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K130498
Bacterin International, Inc.
Orthopedic · 94d
Cleared Mar 06, 2013
CLEARED UNDER GRAFTON II EDBM
K122513
Medtronic Sofamor Danek, Inc.
Orthopedic · 201d
Cleared Nov 15, 2012
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728
Hans Biomed Corp.
Orthopedic · 332d
Cleared Mar 17, 2011
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742
Integra Life Sciences
Orthopedic · 84d
Cleared Oct 10, 2008
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
K080399
Musculoskeletal Transplant Foundation
Orthopedic · 239d
Cleared Aug 28, 2008
SYGNAL DBM
K080405
Musculoskeletal Transplant Foundation
Orthopedic · 196d
Cleared Apr 28, 2008
CAP PLUS, EQUIVABONE, CAP/DBM
K080329
Etex Corp.
Orthopedic · 81d
Cleared Feb 28, 2008
SYGNAL DBM
K073329
Musculoskeletal Transplant Foundation
Orthopedic · 93d
Cleared Jun 07, 2007
OPTECURE
K063685
Exactech, Inc.
Orthopedic · 177d
Cleared Mar 05, 2007
DBX DEMINERALIZED BONE MATRIX MIX
K063676
Musculoskeletal Transplant Foundation
Orthopedic · 84d
Cleared Feb 08, 2007
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
K061131
Orthocon, Inc.
Orthopedic · 290d
Cleared Feb 07, 2007
PLEXUR P
K061982
Osteotech, Inc.
Orthopedic · 209d
Cleared Feb 05, 2007
DBX STRIP
K062205
Musculoskeletal Transplant Foundation
Orthopedic · 188d
Cleared Dec 18, 2006
PROGENIX DBM PUTTY AND PASTE
K060794
Medtronic Sofamor Danek
Orthopedic · 270d
Cleared Sep 12, 2006
OPTECURE +CCC
K061668
Exactech, Inc.
Orthopedic · 90d
Cleared Sep 06, 2006
BIOSET XC
K060180
Regeneration Technologies, Inc.
Orthopedic · 226d
Cleared Mar 21, 2006
AFT ALLOGRAFT FILLER TUBE
K060161
Musculoskeletal Transplant Foundation
Orthopedic · 60d
Cleared Feb 08, 2006
OPTECURE
K050806
Exactech, Inc.
Orthopedic · 315d
Cleared Jan 26, 2006
OSTEOSET DBM PELLETS
K053642
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Jan 13, 2006
DBX STRIP
K042829
Musculoskeletal Transplant Foundation
Orthopedic · 458d
Cleared Dec 28, 2005
ALLOCRAFT DBM
K052735
Lifecell Corp.
Orthopedic · 89d

About Product Code MBP - Regulatory Context

510(k) Submission Activity

31 total 510(k) submissions under product code MBP since 2005, with 31 receiving FDA clearance (average review time: 179 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MBP Product Code

Recent submissions under MBP have taken an average of 65 days to reach a decision - down from 183 days historically, suggesting improved FDA processing for this classification.

MBP devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →