510(k) Report

Devices descending from K042091

345 later devices reach Biolox Delta Ceramic Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+5K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K131986Corin Minihip StemCorin USA20133—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+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—
+6K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, 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—
+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—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+6K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K201084Physica systemLima Corporate S.P.A.20205—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+6K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+6K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+6K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K130634Corin Metafix Hip StemCorin USA20135—
+6K121563Corin Trifit TS HipCorin USA2012101
+6K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+6K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+7K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+7K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+7K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+7K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+7K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K210554Physica systemLima Corporate S.P.A.20212—
+7K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—