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)
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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
Mar 18, 2020K200113LINK TrabecuLink Tibial Cones
Waldemar Link GmbH & Co. KG, DE
MBH
Aug 15, 2019K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
MBH
Nov 26, 2018K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
Exactech, Inc.
MBH
Sep 28, 2018K181794Truliant Porous Femoral Components
Exactech, Inc.
MBH
May 17, 2018K172524Zimmer Persona Personalized Knee System
Zimmer, Inc.
MBH
May 4, 2018K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION®
Microport Orthopedics, Inc.
MBH
Feb 2, 2018K173849Triathlon Total Knee System
Stryker Orthopaedics
MBH
Jan 30, 2018K173417Zimmer Persona Personalized Knee System
Zimmer, Inc.
MBH
Nov 16, 2017K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
MBH
Nov 7, 2017K171365Arthrex Knee Systems
Arthrex, Inc.
MBH
Oct 4, 2017K171991EMPOWR Porous Knee System
Encore Medical L.P.
MBH
Jun 15, 2017K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY®
Microport Orthopedics, Inc.
MBH
Oct 27, 2016K162256Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
Total Joint Orthopedics, Inc.
MBH
May 10, 2016K153657Vanguard XP Knee System
Biomet, Inc.
MBH
Mar 10, 2016K153776Optetrak One Logic Femoral Components
Exactech, Inc.
MBH
Feb 19, 2016K153586Arthrex iBalance TKA System
Arthrex, Inc.
MBH
Nov 16, 2015K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOF
Microport Orthopedics, Inc.
MBH
Nov 16, 2015K152252Arthrex iBalance TKA System
Arthrex, Inc.
MBH
Sep 25, 2015K150832U2 Femoral Component, CR, Porous Coated, Additional Sizes
United Orthopedic Corporation, TW
MBH
Jun 26, 2015K150680Freedom Cementless Femoral Component
Maxx Orthopedics, Inc.
MBH
May 20, 2015K150090Zimmer Persona Personalized Knee System
Zimmer, Inc.
MBH
Feb 13, 2015K140881DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
Depuy(Ireland), IE
MBH
Jan 21, 2015K143366ADVANCE Porous Coated Spiked Tibial Base
Microport Orthopedics, Inc.
MBH
Jan 13, 2015K143393Triathlon Tritanium Cone Augments
Stryker Orthopaedics
MBH
Oct 27, 2014K141407VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
Biomet, Inc.
MBH
Sep 3, 2014K141840TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH
Zimmer, Inc.
MBH
Sep 3, 2014K141635ARTHREX IBALANCE TKA SYSTEM
Arthrex, Inc.
MBH
Aug 29, 2014K140735EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
Microport Orthopedics, Inc.
MBH
Aug 5, 2014K141056TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
Stryker Orthopaedics
MBH
Jul 30, 2014K140883VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
Biomet, Inc.
MBH
Jul 30, 2014K140302OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
Exactech, Inc.
MBH
Jun 13, 2014K140075U2 FEMORAL COMPONENT, CR, POROUS COATED
United Orthopedic Corp., TW
MBH
Apr 2, 2014K140257SIGNATURE PLANNER, SIGNATURE GUIDES
Materialise NV, BE
MBH
Dec 11, 2013K132873VANGUARD XP KNEE SYSTEM
Biomet, Inc.
MBH
Nov 26, 2013K132624TRIATHLON TRITANIUM METAL-BACKED PATELLA
Stryker Orthopaedics
MBH
May 3, 2013K123486TRIATHLON TRITANIUM TIBIAL BASEPLATE
Stryker
MBH
Mar 21, 2013K122218ADVANCE TOTAL KNEE SYSTEM-PATELLA
Wrightmedicaltechnologyinc
MBH
Mar 20, 2013K122160VANGUARD XP KNEE SYSTEM
Biomet Manufacturing Corp
MBH
Feb 22, 2013K123459ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
Zimmer, Inc.
MBH
Dec 5, 2012K122745ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
Zimmer, Inc.
MBH
Nov 7, 2012K121771ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
Zimmer, Inc.
MBH
Oct 24, 2012K122053SHAPEMATCH CUTTING GUIDE
Stryker Corp.
MBH
Aug 7, 2012K121393SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
Smith & Nephew, Inc.
MBH
Jun 29, 2012K120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
Zimmer Trabecular Metal Technology
MBH
Oct 17, 2011K103598PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
Wrightmedicaltechnologyinc
MBH
Jun 27, 2011K110950CONSENSUS KNEE SYSTEM
Consensus Orthopedics, Inc.
MBH
May 19, 2011K110533STRYKER PATIENT SPECIFIC CUTTING GUIDE
Stryker Corp.
MBH
Feb 15, 2011K103517TRABECULAR METAL FEMORAL CONE AUGMENTS
Zimmer Trabecular Metal Technology, Inc.
MBH
Jan 26, 2011K102927CONSENSUS KNEE SYSTEM
Consensus Orthopedics, Inc.
MBH
Dec 13, 2010K102896TRABECULAR METAL TIBIAL CONE AUGMENTS
Zimmer Trabecular Metal Technology
MBH

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