510(k) Report

Devices descending from K010170

297 later devices reach Trident Porous Titanium Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K151264Restoration Anatomic ShellStryker Orthopaedics20151817
+1K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+1K142462Restoration Anatomic ShellStryker Orthopaedics201419—
+1K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+1K103233Modular Dual Mobility Liner, X3 Acetabular InsertHowmedica Osteonics Corp.2011521
+1K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+1K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+1K013475Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp.2001216—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+2K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+2K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K200854DePuy PINNACLE Dual Mobility LinerDepuy Ireland UC20207—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+2K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+2K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+2K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+2K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+2K112556Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 InsertsHowmedica Osteonics Corp.2011101
+2K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+2K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+2K042344Excia Total Hip SystemAesculap, Inc.200519810
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K231522EMPHASYS™ Dual Mobility SystemDepuy Ireland UC20240—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K202484Cordera Hip SystemConformis, Inc.202022
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K191831MobiliT CupCorin U.S.A. Limited20203—
+3K192198Conformis Hip SystemConformis, Inc.2019121
+3K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+3K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+3K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+3K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+3K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+3K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—