510(k) Report

Devices descending from K951000

405 later devices reach ZTT I and II Acetabular Cup of the S-Rom Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.20182—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+6K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+6K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+6K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+6K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+6K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+6K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+6K132959Depuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc.201413—
+6K132879Mpact ExtensionMedacta International201411—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K131986Corin Minihip StemCorin USA20133—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+6K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+6K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+6K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+6K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+6K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+6K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+6K111145Endo HeadMedacta International20110—
+6K111911Corin Optimom Modular HeadCorin USA201162—
+6K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+6K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+6K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+6K083312Minihip StemCorin USA201015—
+6K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+6K081023Evolis Total Knee SystemMedacta International S.A.2008781
+6K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+7K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+7K211891DM Converter - TiN coatedMedacta International S.A.20220—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+7K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+7K202484Cordera Hip SystemConformis, Inc.202022
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+7K191831MobiliT CupCorin U.S.A. Limited20203—
+7K192198Conformis Hip SystemConformis, Inc.2019121
+7K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+7K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+7K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+7K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+7K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+7K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+7K142069GMK ExtensionMedacta International20144—
+7K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+7K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+7K131310GMK Full PE Tibial ComponentsMedacta International20132—
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K123692Pipeline Knee SystemPipeline Orthopedics20130—
+7K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+7K121416GMK SphereMedacta International201220—