510(k) Report

Devices descending from K071535

217 later devices reach Biolox Delta Ceramic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+3K130128Trinity Acetabular SystemCorin Medical201317—
+3K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+3K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+3K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+3K111911Corin Optimom Modular HeadCorin USA201162—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131986Corin Minihip StemCorin USA20133—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K130634Corin Metafix Hip StemCorin USA20135—
+5K121563Corin Trifit TS HipCorin USA2012101
+5K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—