510(k) Report

Devices descending from K100412

140 later devices reach Biolox Delta Ceramic Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K141327Minima S SystemLima Corporate S.P.A.20145—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+1K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+1K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+1K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+1K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+2K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K231925MINIMA S SystemLima Corporate S.P.A.20230—
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+2K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+2K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+2K131518Mectacer Biolox Option HeadsMedacta International20130—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K131647Trinity Acetabular SystemCorin USA201322—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+2K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+2K130128Trinity Acetabular SystemCorin Medical201317—
+2K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+2K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+2K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+2K111911Corin Optimom Modular HeadCorin USA201162—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+3K191831MobiliT CupCorin U.S.A. Limited20203—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K131952Corin Metafix Hip StemCorin USA20134—
+3K131986Corin Minihip StemCorin USA20133—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+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—
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+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—