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..

144
Total
144
Cleared
120d
Avg days
2003
Since
144 devices
49–72 of 144
Cleared Mar 18, 2020
LINK TrabecuLink Tibial Cones
K200113
Waldemar Link GmbH & Co. KG
Orthopedic · 61d
Cleared Aug 15, 2019
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
K190991
Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
Orthopedic · 122d
Cleared Nov 26, 2018
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
K182346
Exactech, Inc.
Orthopedic · 90d
Cleared Sep 28, 2018
Truliant Porous Femoral Components
K181794
Exactech, Inc.
Orthopedic · 85d
Cleared May 17, 2018
Zimmer Persona Personalized Knee System
K172524
Zimmer, Inc.
Orthopedic · 269d
Cleared May 04, 2018
EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
K180317
Microport Orthopedics, Inc.
Orthopedic · 88d
Cleared Feb 02, 2018
Triathlon Total Knee System
K173849
Stryker Orthopaedics
Orthopedic · 45d
Cleared Jan 30, 2018
Zimmer Persona Personalized Knee System
K173417
Zimmer, Inc.
Orthopedic · 90d
Cleared Nov 16, 2017
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
K172634
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic · 76d
Cleared Nov 07, 2017
Arthrex Knee Systems
K171365
Arthrex, Inc.
Orthopedic · 182d
Cleared Oct 04, 2017
EMPOWR Porous Knee System
K171991
Encore Medical, L.P.
Orthopedic · 93d
Cleared Jun 15, 2017
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
K170288
Microport Orthopedics, Inc.
Orthopedic · 136d
Cleared Oct 27, 2016
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
K162256
Total Joint Orthopedics, Inc.
Orthopedic · 77d
Cleared May 10, 2016
Vanguard XP Knee System
K153657
Biomet, Inc.
Orthopedic · 141d
Cleared Mar 10, 2016
Optetrak One Logic Femoral Components
K153776
Exactech, Inc.
Orthopedic · 70d
Cleared Feb 19, 2016
Arthrex iBalance TKA System
K153586
Arthrex, Inc.
Orthopedic · 65d
Cleared Nov 16, 2015
Arthrex iBalance TKA System
K152252
Arthrex, Inc.
Orthopedic · 98d
Cleared Nov 16, 2015
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base
K152298
Microport Orthopedics, Inc.
Orthopedic · 95d
Cleared Sep 25, 2015
U2 Femoral Component, CR, Porous Coated, Additional Sizes
K150832
United Orthopedic Corporation
Orthopedic · 179d
Cleared Jun 26, 2015
Freedom Cementless Femoral Component
K150680
Maxx Orthopedics, Inc.
Orthopedic · 101d
Cleared May 20, 2015
Zimmer Persona Personalized Knee System
K150090
Zimmer, Inc.
Orthopedic · 124d
Cleared Feb 13, 2015
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
K140881
Depuy(Ireland)
Orthopedic · 312d
Cleared Jan 21, 2015
ADVANCE Porous Coated Spiked Tibial Base
K143366
Microport Orthopedics, Inc.
Orthopedic · 58d
Cleared Jan 13, 2015
Triathlon Tritanium Cone Augments
K143393
Stryker Orthopaedics
Orthopedic · 48d