510(k) Report

Devices descending from K953490

214 later devices reach Trilogy Acetabular Shell & Liners 36MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+4K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+4K111145Endo HeadMedacta International20110—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K251834Persona Partial KneeZimmer Biomet20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, 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—
+5K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+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—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+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—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+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—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+5K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+6K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.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—
+6K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+6K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+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—
+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—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+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—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K201084Physica systemLima Corporate S.P.A.20205—
+6K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+6K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+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—