510(k) Report

Devices descending from K030047

181 later devices reach Freedom Constrained Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+3K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+3K123550Utf Stem, ReducedUnited Orthopedic Corporation20134—
+3K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K232371Actinia® hip stemsImplantcast GmbH20231—