510(k) Report

Devices descending from K050327

289 later devices reach E-Poly (Vitamin E) Acetabular Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+4K121727Movation Knee SystemEncore Medical L.P.201214—
+4K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+4K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+5K261453G7® Acetabular SystemZimmer Biomet20260—
+5K262057GMK ExtensionMedacta International SA20260—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K251834Persona Partial KneeZimmer Biomet20250—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+5K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+5K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+5K172651FMP Extended LinersEncore Medical L.P.20173—
+5K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+5K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+5K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+5K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+5K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+5K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+5K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+5K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+5K140830Exprt Revision KneeEncore Medical L.P.201471
+5K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+5K141006RSP Humeral Socket InsertDjo Global2014212
+5K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+6K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+6K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—