510(k) Report

Devices descending from K926107

481 later devices reach Arcom Polyethylene Acetabular Liners & Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+8K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+8K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+8K250450Coated hip implantsMedacta International S.A.20250—
+8K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+8K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+8K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+8K230078TRAX® CR Total Knee SystemAmplitude20230—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+8K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+8K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+8K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+8K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+8K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+8K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+8K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+8K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+8K211866Bencox THR SystemCorentec Co., Ltd.20210—
+8K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+8K203421Triathlon AS-1Conformis, Inc.20210—
+8K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+8K210551Persona Revision Knee SystemZimmer, Inc.202101
+8K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+8K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+8K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+8K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+8K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+8K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+8K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+8K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+8K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+8K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+8K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+8K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+8K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+8K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+8K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+8K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+8K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+8K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+8K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+8K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+8K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+8K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+8K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+8K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+8K131952Corin Metafix Hip StemCorin USA20134—
+8K131986Corin Minihip StemCorin USA20133—
+8K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+8K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+9K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+9K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+9K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+9K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+9K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+9K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+9K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+9K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+9K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+9K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+9K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+9K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+9K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+9K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+9K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+9K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+9K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+9K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+9K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+9K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+9K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+9K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+9K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+9K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+9K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+9K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+9K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+9K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+9K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+9K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+9K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+9K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+9K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+9K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+9K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+9K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+9K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+9K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+9K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+9K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+9K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+9K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+9K130634Corin Metafix Hip StemCorin USA20135—