510(k) Report

Devices descending from K040191

267 later devices reach Bicontact Hip Stem and Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K162035GMK SphereMedacta International S.A.201710—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K140826GMK Sphere ExtensionMedacta International201417—
+4K133630GMK Short StemMedacta International20131—
+4K131986Corin Minihip StemCorin USA20133—
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K123721GMK Revision ExtensionMedacta International20133—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K122232GMK NarrowMedacta International20128—
+4K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111911Corin Optimom Modular HeadCorin USA201162—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+4K103721Mpact Acetabular SystemMedacta International201121—
+4K103352Versafitcup CC TrioMedacta International20114—
+4K102437GMK Revision Knee SystemMedacta International S.A.201034—
+4K093806Myknee Cutting BlocksMedacta International S.A.201016—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K231037MyKnee UNI-STMedacta International S.A.20230—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193559NextAR TKA PlatformMedacta Inernational SA202012—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+5K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K132879Mpact ExtensionMedacta International201411—
+5K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K111145Endo HeadMedacta International20110—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—