FDA Product Code MBH: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Under FDA product code MBH, semi-constrained patello/femorotibial knee prostheses are cleared for total knee arthroplasty with patellar resurfacing.
These implant systems include components for the femur, tibia, and patella, restoring all three compartments of the knee joint. They are designed to provide stability, range of motion, and durability in patients with tricompartmental arthritis.
MBH devices are Class II medical devices, regulated under 21 CFR 888.3565 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Depuy Ireland UC, Zimmer, Inc. and Lima Corporate S.P.A..
FDA 510(k) Cleared Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer Devices (Product Code MBH)
About Product Code MBH - Regulatory Context
510(k) Submission Activity
142 total 510(k) submissions under product code MBH since 2003, with 142 receiving FDA clearance (average review time: 118 days).
Submission volume has increased in recent years - 19 submissions in the last 24 months compared to 11 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for MBH submissions have been consistent, averaging 111 days recently vs 119 days historically.
MBH devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →