FDA Product Code MBB: Bone Cement, Antibiotic
FDA product code MBB covers antibiotic-impregnated bone cements used in orthopedic surgery.
These cements incorporate antibiotics — typically gentamicin or tobramycin — directly into the PMMA matrix, providing sustained local antibiotic elution at the implant-bone interface. They are used to reduce the risk of periprosthetic joint infection and as spacers in the treatment of established infections.
MBB devices are Class II medical devices, regulated under 21 CFR 888.3027 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Biomet, Inc., Osartis GmbH and Teknimed Sas.
FDA 510(k) Cleared Bone Cement, Antibiotic Devices (Product Code MBB)
About Product Code MBB - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code MBB since 2005, with 19 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
FDA review times for MBB submissions have been consistent, averaging 140 days recently vs 127 days historically.
MBB devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →