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..

146
Total
146
Cleared
121d
Avg days
2003
Since
Growing category - 18 submissions in the last 2 years vs 13 in the prior period
Review times increasing: avg 138d recently vs 118d historically

FDA 510(k) Cleared Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer Devices (Product Code MBH)

146 devices
1–24 of 146
Cleared Sep 17, 2026
Unity Total Knee System, Unity Knee Cementless CR Femur
K261275
Corin, Ltd.
Orthopedic · 153d
Cleared Sep 08, 2026
LANDMARK Total Knee System
K261462
Smith & Nephew, Inc.
Orthopedic · 127d
Cleared Aug 21, 2026
EVOLUTION® AM BIOFOAM® Tibial System
K253728
Microport Orthopedics, Inc.
Orthopedic · 270d
Cleared May 28, 2026
Zimmer® Persona® Personalized Knee System
K251840
Zimmer, Inc.
Orthopedic · 346d
Cleared Mar 09, 2026
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
K253189
Zimmer, Inc.
Orthopedic · 164d
Cleared Feb 26, 2026
GMK 3D Metal Tibial Tray Extension
K253328
Medacta International S.A.
Orthopedic · 149d
Cleared Feb 18, 2026
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
K253637
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 91d
Cleared Dec 23, 2025
Active-V Total Knee System
K253239
Signature Orthopaedics Pty, Ltd.
Orthopedic · 85d
Cleared Dec 19, 2025
Balanced Knee System TriMax Porous Femoral Components
K253161
Ortho Development Corp.
Orthopedic · 84d
Cleared Oct 31, 2025
Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
K252777
Maxx Orthopedics, Inc.
Orthopedic · 59d
Cleared Oct 24, 2025
Triathlon® Total Knee System - Triathlon® Gold Femoral Components
K252044
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 116d
Cleared Jul 31, 2025
U2 Total Knee System – PF+ Patella
K243656
United Orthopedic Corporation
Orthopedic · 247d
Cleared May 22, 2025
Physica System (Physica CR Porous Femoral components)
K250980
Lima Corporate S.P.A.
Orthopedic · 52d
Cleared Mar 27, 2025
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
K243768
Restor3D, Inc.
Orthopedic · 111d
Cleared Feb 13, 2025
Freedom® Total Knee System - Porous Tibial Base Plate
K241597
Maxx Orthopedics, Inc.
Orthopedic · 255d
Cleared Dec 20, 2024
Zimmer® Persona® Personalized Knee System
K243293
Zimmer Biomet
Orthopedic · 63d
Cleared Dec 18, 2024
Physica Porous Femoral Components
K243615
Lima Corporate S.P.A.
Orthopedic · 26d
Cleared Nov 22, 2024
Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
K242543
Zimmer, Inc.
Orthopedic · 88d
Cleared Nov 06, 2024
Agility Symmetric™ Total Knee System
K242412
Medisurge, LLC
Orthopedic · 84d
Cleared Oct 29, 2024
Persona the Personalized Knee System
K243247
Zimmer, Inc.
Orthopedic · 18d
Cleared Oct 03, 2024
Exactech® TRULIANT® Knee System
K240393
Exactech, Inc.
Orthopedic · 238d
Cleared Jun 27, 2024
The Optimotion™ Blue Plus Knee System
K240938
Optimotion Implants, LLC
Orthopedic · 83d
Cleared Jun 18, 2024
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
K240678
Depuy Ireland UC
Orthopedic · 99d
Cleared Apr 26, 2024
Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
K240299
Zimmer, Inc.
Orthopedic · 85d

About Product Code MBH - Regulatory Context

510(k) Submission Activity

146 total 510(k) submissions under product code MBH since 2003, with 146 receiving FDA clearance (average review time: 121 days).

Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MBH Product Code

Recent submissions under MBH have taken an average of 138 days to reach a decision - up from 118 days historically. Manufacturers should account for longer review timelines in current project planning.

MBH devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →