510(k) Report

Devices descending from K031803

377 later devices reach Depuy Ceramic Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+5K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+5K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K111911Corin Optimom Modular HeadCorin USA201162—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+6K261453G7® Acetabular SystemZimmer Biomet20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K251834Persona Partial KneeZimmer Biomet20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+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—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+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—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+6K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+6K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+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—
+6K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+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—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+6K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K191625Persona Revision Knee SystemZimmer, Inc.201911
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+6K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+6K182099Delta TT ProLima Corporate S.P.A.20183—
+6K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+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
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+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
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+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—
+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—