MBH · Class II · 21 CFR 888.3565

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
25–48 of 143
Cleared Jul 21, 2023
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
K223316
Conformis, Inc.
Orthopedic · 266d
Cleared Mar 10, 2023
ATTUNE® Revision Cones
K230295
Depuy Ireland UC
Orthopedic · 36d
Cleared Feb 28, 2023
U2 Total Knee System-PF+
K221705
United Orthopedic Corporation
Orthopedic · 260d
Cleared Jan 20, 2023
GMK Sphere & GMK SpheriKA Cementless
K223548
Medacta International S.A.
Orthopedic · 56d
Cleared Oct 17, 2022
ATTUNE Revision Cones
K212746
Depuy Ireland UC
Orthopedic · 413d
Cleared Oct 17, 2022
Zimmer Persona Personalized Knee System
K222566
Zimmer, Inc.
Orthopedic · 54d
Cleared Aug 23, 2022
GMK 3D Metal Tibial Tray
K221850
Medacta International S.A.
Orthopedic · 57d
Cleared Mar 14, 2022
Optimotion Implants Porous Metal-Backed Patella
K220049
Optimotion Implants, LLC
Orthopedic · 67d
Cleared Jan 20, 2022
Porous Patella
K212941
Encore Medical, L.P. Dba Djo Surgical
Orthopedic · 127d
Cleared Jan 18, 2022
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
K213781
Depuy Ireland UC
Orthopedic · 46d
Cleared Jan 05, 2022
MPO Knee Instruments
K213817
Microport Orthopedics, Inc.
Orthopedic · 29d
Cleared Oct 01, 2021
Porous Patella and Porous Tibia Baseplate
K211221
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Jun 10, 2021
Symmetric Total Knee System
K203779
Signal Medical Corporation
Orthopedic · 164d
Cleared May 24, 2021
LEGION CR Porous Plus HA Femoral Components
K211246
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 06, 2021
Physica system
K210554
Lima Corporate S.P.A.
Orthopedic · 40d
Cleared Mar 30, 2021
EMPOWR Porous Femur with HAnano SurfaceTM
K210308
Encore Medical, L.P.
Orthopedic · 55d
Cleared Mar 25, 2021
LEGION Porous CR Narrow Femoral Components
K210566
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Dec 14, 2020
Physica system
K201084
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
K202194
Depuy Ireland UC
Orthopedic · 112d
Cleared Aug 12, 2020
UNIKO PointCloud™ Knee Instruments
K193312
Unik Orthopedics, Inc.
Orthopedic · 257d
Cleared Jul 17, 2020
LINK TrabecuLink Femoral Cones
K201364
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
K200782
Howmedica Osteonics Corp.
Orthopedic · 48d
Cleared Apr 07, 2020
The Optimotion Blue Total Knee System
K191084
Optimotion Implants, LLC
Orthopedic · 349d
Cleared Mar 18, 2020
LINK TrabecuLink Tibial Cones
K200113
Waldemar Link GmbH & Co. KG
Orthopedic · 61d