MBP · Class II · 21 CFR 888.3045

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

Leading manufacturers include Lifenet Health.

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

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 Review Time

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 →