510(k) Report

Devices descending from K042051

355 later devices reach Arcomxl Polyethylene Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+6K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+6K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+6K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+6K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K191625Persona Revision Knee SystemZimmer, Inc.201911
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+6K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+6K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K131986Corin Minihip StemCorin USA20133—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+7K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+7K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+7K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+7K250450Coated hip implantsMedacta International S.A.20250—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+7K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+7K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+7K230078TRAX® CR Total Knee SystemAmplitude20230—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+7K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K211938Physica LMC Knee SystemLimacorporate20210—
+7K210551Persona Revision Knee SystemZimmer, Inc.202101
+7K201084Physica systemLima Corporate S.P.A.20205—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+7K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+7K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+7K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K121563Corin Trifit TS HipCorin USA2012101
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+7K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+7K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+7K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+8K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+8K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+8K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+8K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+8K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—