510(k) Report

Devices descending from K902365

185 later devices reach Modular Unipolar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K063791Corin Unipolar Modular HeadCorin USA200763—
+1K014226Unitrax Modular Unipolar SystemHowmedica Osteonics Corp.2002183
+1K960538Opteon UnipolarExactech, Inc.1996121—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+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—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+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
+2K111911Corin Optimom Modular HeadCorin USA201162—
+2K010081Acumatch L-Series Unipolar EndoprosthesisExactech, Inc.20012—
+2K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999117—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.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—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+3K042037M2A Magnum SystemBiomet, Inc.2004116—
+3K021109Esop CO-CR Femoral HeadsFournitures Hospitalieres20021—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131647Trinity Acetabular SystemCorin USA201322—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K130634Corin Metafix Hip StemCorin USA20135—
+4K121563Corin Trifit TS HipCorin USA2012101
+4K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+4K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+4K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+4K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+4K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+4K062995M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp200626—
+4K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+4K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH20067413
+4K050556Alumina HeadFournitures Hospitalieres Industrie20050—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+5K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+5K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+5K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+5K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+5K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+5K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+5K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+5K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K201673SMS Cementless StemMedacta International S.A.20203—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+6K192236Fitmore Hip StemZimmer GmbH20191—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+6K181693SMS Femoral StemMedacta International S.A.20184—
+6K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K170072Fitmore® Hip StemZimmer GmbH20170—