510(k) Report

Devices descending from K043537

160 later devices reach Taperloc 12/14 Taper Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+3K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+3K182099Delta TT ProLima Corporate S.P.A.20183—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+3K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+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—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K232371Actinia® hip stemsImplantcast GmbH20231—