510(k) Report

Devices descending from K953490

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+1K092443Interface Acetabular Cup LinersOmni Life Science, Inc.20091—
+1K990135Trilogy Acetabular System Longevity Crosslinked PolyethyleneZimmer, Inc.1999192—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+2K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+2K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+2K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+2K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K182099Delta TT ProLima Corporate S.P.A.20183—
+2K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+2K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.20182—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+2K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+2K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc.2011137—
+2K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+2K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+3K261453G7® Acetabular SystemZimmer Biomet20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K151448Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsZimmer, Inc.20156—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+3K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+3K131458Mpact DM Liner ConverterMedacta International20133—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+3K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+3K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+3K123019Longevity IT Highly Crosslinked Polyethyene LinersZimmer, Inc.20120—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103352Versafitcup CC TrioMedacta International20114—
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K211891DM Converter - TiN coatedMedacta International S.A.20220—
+4K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K181947Persona Revision Knee SystemZimmer, Inc.201841
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K161592Persona Partial Knee SystemBiomet, Inc.201652
+4K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+4K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—