ClearanceBrief
Panels › Orthopedic › Product code MBH · Class 2

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Regulation 888.3565

9510(k)s in 12 months (146 all time)
4recalls in 12 months (103 all time)
103recalls that name a 510(k)
Get daily alerts for MBHSample briefCSV

Top companies in MBH

Company510(k)sRecalls
Zimmer, Inc.1919
Howmedica Osteonics Corp.920
Microport Orthopedics, Inc.812
DePuy Orthopaedics, Inc.215
Smith & Nephew, Inc.124
Zimmer Biomet112
Biomet, Inc.74
Wrightmedicaltechnologyinc80
Zimmer Trabecular Metal Technology35
Biomet Manufacturing Corp60
Decided510(k)Device and applicantCode
Sep 17, 2026K261275Unity Total Knee System, Unity Knee Cementless CR Femur
Corin, Ltd., GB
MBH
Sep 8, 2026K261462LANDMARK Total Knee System
Smith & Nephew, Inc.
MBH
Aug 21, 2026K253728EVOLUTION® AM BIOFOAM® Tibial System
Microport Orthopedics, Inc.
MBH
May 28, 2026K251840Zimmer® Persona® Personalized Knee System
Zimmer, Inc.
MBH
Mar 9, 2026K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
Zimmer, Inc.
MBH
Feb 26, 2026K253328GMK 3D Metal Tibial Tray Extension
Medacta International S.A., CH
MBH
Feb 18, 2026K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
MBH
Dec 23, 2025K253239Active-V Total Knee System; World Total Knee System
Signature Orthopaedics Pty, Ltd., AU
MBH
Dec 19, 2025K253161Balanced Knee System TriMax Porous Femoral Components
Ortho Development Corp.
MBH
Oct 31, 2025K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
Maxx Orthopedics, Inc.
MBH
Oct 24, 2025K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
MBH
Jul 31, 2025K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella
United Orthopedic Corporation, TW
MBH
May 22, 2025K250980Physica System (Physica CR Porous Femoral components)
Lima Corporate S.P.A., IT
MBH
Mar 27, 2025K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
Restor3D, Inc.
MBH
Feb 13, 2025K241597Freedom® Total Knee System - Porous Tibial Base Plate
Maxx Orthopedics, Inc.
MBH
Dec 20, 2024K243293Zimmer® Persona® Personalized Knee System
Zimmer Biomet
MBH
Dec 18, 2024K243615Physica Porous Femoral Components
Lima Corporate S.P.A., IT
MBH
Nov 22, 2024K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
Zimmer, Inc.
MBH
Nov 6, 2024K242412Agility Symmetric™ Total Knee System
Medisurge, LLC
MBH
Oct 29, 2024K243247Persona the Personalized Knee System
Zimmer, Inc.
MBH
Oct 3, 2024K240393Exactech® TRULIANT® Knee System
Exactech, Inc.
MBH
Jun 27, 2024K240938The Optimotion™ Blue Plus Knee System
Optimotion Implants, LLC
MBH
Jun 18, 2024K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Tech
Depuy Ireland UC, IE
MBH
Apr 26, 2024K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
Zimmer, Inc.
MBH
Jan 18, 2024K233507EVOLUTION® Tibial Cones
Microport Orthopedics, Inc.
MBH
Dec 11, 2023K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Tec
Depuy Ireland UC, IE
MBH
Sep 8, 2023K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
Conformis, Inc.
MBH
Jul 21, 2023K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement
Conformis, Inc.
MBH
Mar 10, 2023K230295ATTUNE® Revision Cones
Depuy Ireland UC, IE
MBH
Feb 28, 2023K221705U2 Total Knee System-PF+
United Orthopedic Corporation, TW
MBH
Jan 20, 2023K223548GMK Sphere & GMK SpheriKA Cementless
Medacta International S.A., CH
MBH
Oct 17, 2022K222566Zimmer Persona Personalized Knee System
Zimmer, Inc.
MBH
Oct 17, 2022K212746ATTUNE Revision Cones
Depuy Ireland UC, IE
MBH
Aug 23, 2022K221850GMK 3D Metal Tibial Tray
Medacta International S.A., CH
MBH
Mar 14, 2022K220049Optimotion Implants Porous Metal-Backed Patella
Optimotion Implants, LLC
MBH
Jan 20, 2022K212941Porous Patella
Encore Medical, L.P. Dba Djo Surgical
MBH
Jan 18, 2022K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
Depuy Ireland UC, IE
MBH
Jan 5, 2022K213817MPO Knee Instruments; MPO PROPHECY Knee Instruments
Microport Orthopedics, Inc.
MBH
Oct 1, 2021K211221Porous Patella and Porous Tibia Baseplate
Smith & Nephew, Inc.
MBH
Jun 10, 2021K203779Symmetric Total Knee System
Signal Medical Corporation
MBH
May 24, 2021K211246LEGION CR Porous Plus HA Femoral Components
Smith & Nephew, Inc.
MBH
Apr 6, 2021K210554Physica system
Lima Corporate S.P.A., IT
MBH
Mar 30, 2021K210308EMPOWR Porous Femur with HAnano SurfaceTM
Encore Medical L.P.
MBH
Mar 25, 2021K210566LEGION Porous CR Narrow Femoral Components
Smith & Nephew, Inc.
MBH
Dec 14, 2020K201084Physica system
Lima Corporate S.P.A., IT
MBH
Nov 25, 2020K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Te
Depuy Ireland UC, IE
MBH
Aug 12, 2020K193312UNIKO PointCloud™ Knee Instruments
Unik Orthopedics, Inc.
MBH
Jul 17, 2020K201364LINK TrabecuLink Femoral Cones
Waldemar Link GmbH & Co. KG, DE
MBH
May 13, 2020K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Compon
Howmedica Osteonics Corp.
MBH
Apr 7, 2020K191084The Optimotion Blue Total Knee System
Optimotion Implants, LLC
MBH

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.