FDA 510(k) Applications for Medical Device Product Code "MBH"
(Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K032108 | AESCULAP, INC. | SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) | 01/15/2004 |
| K171365 | Arthrex Inc. | Arthrex Knee Systems | 11/07/2017 |
| K152252 | ARTHREX, INC. | Arthrex iBalance TKA System | 11/16/2015 |
| K141635 | ARTHREX, INC. | ARTHREX IBALANCE TKA SYSTEM | 09/03/2014 |
| K153586 | Arthrex, Inc. | Arthrex iBalance TKA System | 02/19/2016 |
| K041872 | BIOMET MANUFACTURING CORP. | ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS | 09/08/2004 |
| K083782 | BIOMET MANUFACTURING CORP. | REGENEREX PATELLA COMPONENTS | 04/03/2009 |
| K060303 | BIOMET MANUFACTURING CORP. | VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS | 03/30/2006 |
| K122160 | BIOMET MANUFACTURING CORP. | VANGUARD XP KNEE SYSTEM | 03/20/2013 |
| K053505 | BIOMET MANUFACTURING, INC. | REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS | 08/14/2006 |
| K061433 | BIOMET MANUFACTURING, INC. | VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE | 08/21/2006 |
| K033489 | BIOMET, INC. | AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN | 06/02/2004 |
| K080361 | BIOMET, INC. | REGENEREX TIBIAL COMPONENTS | 04/21/2008 |
| K140883 | BIOMET, INC. | VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT | 07/30/2014 |
| K050222 | BIOMET, INC. | VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS | 08/16/2005 |
| K141407 | BIOMET, INC. | VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL | 10/27/2014 |
| K132873 | BIOMET, INC. | VANGUARD XP KNEE SYSTEM | 12/11/2013 |
| K153657 | BIOMET, INC. | Vanguard XP Knee System | 05/10/2016 |
| K232426 | Conformis Inc | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | 09/08/2023 |
| K223316 | Conformis Inc. | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | 07/21/2023 |
| K102927 | Consensus Orthopedics, Inc | CONSENSUS KNEE SYSTEM | 01/26/2011 |
| K110950 | CONSENSUS ORTHOPEDICS, INC. | CONSENSUS KNEE SYSTEM | 06/27/2011 |
| K140881 | DEPUY (IRELAND) | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS | 02/13/2015 |
| K212746 | Depuy Ireland UC | ATTUNE Revision Cones | 10/17/2022 |
| K213781 | DePuy Ireland UC | ATTUNE« Porous Fixed Bearing Tibial Base with AFFIXIUMÖ 3DP | 01/18/2022 |
| K202194 | DePuy Ireland UC | ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology | 11/25/2020 |
| K230295 | DePuy Ireland UC | ATTUNE« Revision Cones | 03/10/2023 |
| K071417 | DEPUY ORTHOPAEDICS, INC. | DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES | 08/02/2007 |
| K062654 | DEPUY ORTHOPAEDICS, INC. | DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS | 09/29/2006 |
| K210308 | Encore Medical, L.P. | EMPOWR Porous Femur with HAnano SurfaceTM | 03/30/2021 |
| K171991 | Encore Medical, L.P. | EMPOWR Porous Knee System | 10/04/2017 |
| K212941 | Encore Medical, L.P. dba DJO Surgical | Porous Patella | 01/20/2022 |
| K032905 | ENCORE ORTHOPEDICS, INC. | 3DKNEE POROUS COATED FEMORAL COMPONENT | 07/06/2004 |
| K153776 | Exactech Inc | Optetrak One Logic Femoral Components | 03/10/2016 |
| K140302 | EXACTECH, INC. | OPTETRAK LOGIC POROUS FEMORAL COMPONENTS | 07/30/2014 |
| K181794 | Exactech, Inc. | Truliant Porous Femoral Components | 09/28/2018 |
| K182346 | Exactech, Inc. | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | 11/26/2018 |
| K043374 | HOWMEDICA OSTEONICS CORP | DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING | 02/16/2005 |
| K033972 | HOWMEDICA OSTEONICS CORP | SCORPIO TOTAL KNEE SYSTEM | 04/12/2004 |
| K033971 | HOWMEDICA OSTEONICS CORP | SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING | 05/28/2004 |
| K061521 | HOWMEDICA OSTEONICS CORP | TRIATHLON METAL BACKED PATELLA | 08/11/2006 |
| K051380 | HOWMEDICA OSTEONICS CORP | TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM | 08/30/2005 |
| K172634 | Howmedica Osteonics Corp aka Stryker Orthopaedics | Triathlon« X3« UHMWPE Tibial Inserts and Patellar Components | 11/16/2017 |
| K032163 | HOWMEDICA OSTEONICS CORP. | DURACON TOTAL KNEE SYSTEM | 09/12/2003 |
| K032418 | HOWMEDICA OSTEONICS CORP. | DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING | 09/11/2003 |
| K070883 | HOWMEDICA OSTEONICS CORP. | DURACON X3 CS TIBIAL INSERT | 05/11/2007 |
| K200782 | Howmedica Osteonics Corp. | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | 05/13/2020 |
| K190991 | Howmedica Osteonics Corp. (aka Stryker Orthopaedics) | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | 08/15/2019 |
| K031462 | IMPLEX CORP. | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS | 08/06/2003 |
| K040487 | IMPLEX CORP. | TRABECULAR METAL KNEE SYSTEM AUGMENTS | 12/21/2004 |
| K201084 | LimaCorporate S.p.A. | Physica system | 12/14/2020 |
| K210554 | Limacorporate S.p.A. | Physica system | 04/06/2021 |
| K140257 | MATERIALISE N.V. | SIGNATURE PLANNER, SIGNATURE GUIDES | 04/02/2014 |
| K093533 | MATERIALISE N.V. | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 | 02/17/2010 |
| K150680 | MAXX ORTHOPEDICS, INC. | Freedom Cementless Femoral Component | 06/26/2015 |
| K221850 | Medacta International S.A. | GMK 3D Metal Tibial Tray | 08/23/2022 |
| K223548 | Medacta International S.A. | GMK Sphere & GMK SpheriKA Cementless | 01/20/2023 |
| K143366 | MicroPort Orthopedics Inc. | ADVANCE Porous Coated Spiked Tibial Base | 01/21/2015 |
| K140735 | MICROPORT ORTHOPEDICS INC. | EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS | 08/29/2014 |
| K213817 | MicroPort Orthopedics Inc. | MPO Knee Instruments; MPO PROPHECY Knee Instruments | 01/05/2022 |
| K170288 | MicroPort Orthopedics, Inc. | BIOFOAM« Additive Manufacturing (BIOFOAM« AM), ADVANCE« BIOFOAM« Tibial Base, EVOLUTION« BIOFOAM« Tibial Base, DYNASTY« BIOFOAM« Acetabular Shell | 06/15/2017 |
| K152298 | MICROPORT ORTHOPEDICS, INC. | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base | 11/16/2015 |
| K180317 | MicroPort Orthopedics, Inc. | EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System | 05/04/2018 |
| K080842 | OMNI LIFE SCIENCE, INC. | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] | 05/23/2008 |
| K220049 | Optimotion Implants, LLC | Optimotion Implants Porous Metal-Backed Patella | 03/14/2022 |
| K191084 | Optimotion Implants, LLC | The Optimotion Blue Total Knee System | 04/07/2020 |
| K051510 | SIGNAL MEDICAL CORP. | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM | 03/22/2006 |
| K203779 | Signal Medical Corporation | Symmetric Total Knee System | 06/10/2021 |
| K032683 | SMITH & NEPHEW, INC. | GENESIS II POROUS PLUS HA KNEE SYSTEM | 10/15/2003 |
| K030612 | SMITH & NEPHEW, INC. | GENESIS II TOTAL KNEE SYSTEM | 05/27/2003 |
| K071790 | SMITH & NEPHEW, INC. | GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM | 08/17/2007 |
| K211246 | Smith & Nephew, Inc. | LEGION CR Porous Plus HA Femoral Components | 05/24/2021 |
| K100897 | SMITH & NEPHEW, INC. | LEGION POROUS + HA TIBIAL BASEPLATES | 05/13/2010 |
| K210566 | Smith & Nephew, Inc. | LEGION Porous CR Narrow Femoral Components | 03/25/2021 |
| K091543 | SMITH & NEPHEW, INC. | LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS | 12/21/2009 |
| K073325 | SMITH & NEPHEW, INC. | LEGION POROUS PRIMARY | 12/20/2007 |
| K211221 | Smith & Nephew, Inc. | Porous Patella and Porous Tibia Baseplate | 10/01/2021 |
| K030623 | SMITH & NEPHEW, INC. | SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM | 05/22/2003 |
| K121393 | SMITH & NEPHEW, INC. | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION | 08/07/2012 |
| K123486 | Stryker | TRIATHLON TRITANIUM TIBIAL BASEPLATE | 05/03/2013 |
| K122053 | STRYKER CORP. | SHAPEMATCH CUTTING GUIDE | 10/24/2012 |
| K110533 | STRYKER CORP. | STRYKER PATIENT SPECIFIC CUTTING GUIDE | 05/19/2011 |
| K141056 | STRYKER ORTHOPAEDICS | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | 08/05/2014 |
| K072575 | STRYKER ORTHOPAEDICS | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE | 01/07/2008 |
| K173849 | Stryker Orthopaedics | Triathlon Total Knee System | 02/02/2018 |
| K143393 | STRYKER ORTHOPAEDICS | Triathlon Tritanium Cone Augments | 01/13/2015 |
| K132624 | STRYKER ORTHOPAEDICS | TRIATHLON TRITANIUM METAL-BACKED PATELLA | 11/26/2013 |
| K162256 | TOTAL JOINT ORTHOPEDICS, INC. | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | 10/27/2016 |
| K193312 | Unik Orthopedics, Inc. | UNIKO PointCloudÖ Knee Instruments | 08/12/2020 |
| K140075 | UNITED ORTHOPEDIC CORP. | U2 FEMORAL COMPONENT, CR, POROUS COATED | 06/13/2014 |
| K150832 | UNITED ORTHOPEDIC CORPORATION | U2 Femoral Component, CR, Porous Coated, Additional Sizes | 09/25/2015 |
| K221705 | United Orthopedic Corporation | U2 Total Knee System-PF+ | 02/28/2023 |
| K201364 | Waldemar Link GmbH & Co. KG | LINK TrabecuLink Femoral Cones | 07/17/2020 |
| K200113 | Waldemar Link GmbH & Co. KG | LINK TrabecuLink Tibial Cones | 03/18/2020 |
| K081479 | WRIGHT MEDICAL TECHNOLOGY, INC. | ADVANCE A-CLASS TIBIAL INSERT | 02/20/2009 |
| K043083 | WRIGHT MEDICAL TECHNOLOGY, INC. | ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL | 04/18/2005 |
| K063128 | WRIGHT MEDICAL TECHNOLOGY, INC. | ADVANCE SPIKED POROUS TIBIAL BASE | 03/21/2007 |
| K063731 | WRIGHT MEDICAL TECHNOLOGY, INC. | ADVANCE STATURE FEMORAL COMPONENT | 03/02/2007 |
| K061223 | WRIGHT MEDICAL TECHNOLOGY, INC. | ADVANCE TOTAL KNEE SYSTEM | 08/18/2006 |
| K122218 | WRIGHT MEDICAL TECHNOLOGY, INC. | ADVANCE TOTAL KNEE SYSTEM-PATELLA | 03/21/2013 |
| K093405 | WRIGHT MEDICAL TECHNOLOGY, INC. | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | 05/25/2010 |
| K103598 | WRIGHT MEDICAL TECHNOLOGY, INC. | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | 10/17/2011 |
| K123459 | ZIMMER INC. | ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM | 02/22/2013 |
| K053340 | ZIMMER TRABECULAR | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS | 02/27/2006 |
| K120990 | ZIMMER TRABECULAR METAL TECHNOLOGY | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL | 06/29/2012 |
| K102896 | ZIMMER TRABECULAR METAL TECHNOLOGY | TRABECULAR METAL TIBIAL CONE AUGMENTS | 12/13/2010 |
| K103517 | ZIMMER TRABECULAR METAL TECHNOLOGY, INC. | TRABECULAR METAL FEMORAL CONE AUGMENTS | 02/15/2011 |
| K070214 | ZIMMER, INC. | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM | 03/16/2007 |
| K071107 | ZIMMER, INC. | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON | 07/06/2007 |
| K072619 | ZIMMER, INC. | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS | 11/21/2007 |
| K041100 | ZIMMER, INC. | NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS | 10/29/2004 |
| K031061 | ZIMMER, INC. | NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS | 10/09/2003 |
| K072160 | ZIMMER, INC. | NEXGEN TRABECULAR METAL TIBIAL TRAY | 09/05/2007 |
| K141840 | ZIMMER, INC. | TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH | 09/03/2014 |
| K222566 | Zimmer, Inc. | Zimmer Persona Personalized Knee System | 10/17/2022 |
| K150090 | ZIMMER, INC. | Zimmer Persona Personalized Knee System | 05/20/2015 |
| K172524 | Zimmer, Inc. | Zimmer Persona Personalized Knee System | 05/17/2018 |
| K173417 | Zimmer, Inc. | Zimmer Persona Personalized Knee System | 01/30/2018 |
| K121771 | ZIMMER, INC. | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | 11/07/2012 |
| K122745 | ZIMMER, INC. | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | 12/05/2012 |
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