510(k) Report

Devices descending from K070364

286 later devices reach 100KGY E-Poly Maxrom Acetabular Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+4K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+4K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+4K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+4K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+4K172651FMP Extended LinersEncore Medical L.P.20173—
+4K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+4K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+4K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+4K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+4K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+4K140830Exprt Revision KneeEncore Medical L.P.201471
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+4K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+4K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+5K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+5K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+5K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—