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..
142
Total
142
Cleared
118d
Avg days
2003
Since
142 devices
Cleared
Mar 10, 2023
ATTUNE® Revision Cones
Depuy Ireland UC
Orthopedic
36d
Cleared
Feb 28, 2023
U2 Total Knee System-PF+
United Orthopedic Corporation
Orthopedic
260d
Cleared
Jan 20, 2023
GMK Sphere & GMK SpheriKA Cementless
Medacta International S.A.
Orthopedic
56d
Cleared
Oct 17, 2022
ATTUNE Revision Cones
Depuy Ireland UC
Orthopedic
413d
Cleared
Oct 17, 2022
Zimmer Persona Personalized Knee System
Zimmer, Inc.
Orthopedic
54d
Cleared
Aug 23, 2022
GMK 3D Metal Tibial Tray
Medacta International S.A.
Orthopedic
57d
Cleared
Jan 18, 2022
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
Depuy Ireland UC
Orthopedic
46d
Cleared
Jan 05, 2022
MPO Knee Instruments
Microport Orthopedics, Inc.
Orthopedic
29d
Cleared
Oct 01, 2021
Porous Patella and Porous Tibia Baseplate
Smith & Nephew, Inc.
Orthopedic
161d
Cleared
May 24, 2021
LEGION CR Porous Plus HA Femoral Components
Smith & Nephew, Inc.
Orthopedic
28d
Cleared
Apr 06, 2021
Physica system
Lima Corporate S.P.A.
Orthopedic
40d
Cleared
Mar 30, 2021
EMPOWR Porous Femur with HAnano SurfaceTM
Encore Medical, L.P.
Orthopedic
55d
Cleared
Mar 25, 2021
LEGION Porous CR Narrow Femoral Components
Smith & Nephew, Inc.
Orthopedic
27d