510(k) Report

Devices descending from K961378

384 later devices reach Delta Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+5K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+5K220405Amis K LongMedacta International S.A.20220—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+5K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+5K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+5K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K162775Legion Cone SystemSmith & Nephew, Inc.201752
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+5K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+5K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+5K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+5K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+5K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.2011162
+5K093472Trinity Acetabular SystemCorin USA20101171
+5K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+5K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+5K081023Evolis Total Knee SystemMedacta International S.A.2008781
+5K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+5K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+6K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+6K233476Z1 Hip SystemOrchard Medical Development202421
+6K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+6K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+6K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+6K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+6K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+6K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+6K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+6K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+6K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+6K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+6K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+6K142761Corin TaperFit Hip StemCorin USA201541
+6K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+6K142069GMK ExtensionMedacta International20144—
+6K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+6K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+6K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+6K131647Trinity Acetabular SystemCorin USA201322—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K131310GMK Full PE Tibial ComponentsMedacta International20132—
+6K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+6K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+6K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+6K130128Trinity Acetabular SystemCorin Medical201317—
+6K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234