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 Zimmer, Inc., Smith & Nephew, Inc. and Howmedica Osteonics Corp..
143
Total
143
Cleared
119d
Avg days
2003
Since
143 devices
Cleared
Jul 21, 2023
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
Conformis, Inc.
Orthopedic
266d
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
Mar 14, 2022
Optimotion Implants Porous Metal-Backed Patella
Optimotion Implants, LLC
Orthopedic
67d
Cleared
Jan 20, 2022
Porous Patella
Encore Medical, L.P. Dba Djo Surgical
Orthopedic
127d
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
Jun 10, 2021
Symmetric Total Knee System
Signal Medical Corporation
Orthopedic
164d
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
Cleared
Dec 14, 2020
Physica system
Lima Corporate S.P.A.
Orthopedic
235d
Cleared
Nov 25, 2020
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
Depuy Ireland UC
Orthopedic
112d
Cleared
Aug 12, 2020
UNIKO PointCloud™ Knee Instruments
Unik Orthopedics, Inc.
Orthopedic
257d
Cleared
Jul 17, 2020
LINK TrabecuLink Femoral Cones
Waldemar Link GmbH & Co. KG
Orthopedic
56d
Cleared
May 13, 2020
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
Howmedica Osteonics Corp.
Orthopedic
48d
Cleared
Apr 07, 2020
The Optimotion Blue Total Knee System
Optimotion Implants, LLC
Orthopedic
349d
Cleared
Mar 18, 2020
LINK TrabecuLink Tibial Cones
Waldemar Link GmbH & Co. KG
Orthopedic
61d