510(k) Report

Devices descending from K030733

296 later devices reach Mayo Conservative Hip Prosthesis, Model 8026 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231037MyKnee UNI-STMedacta International S.A.20230—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193559NextAR TKA PlatformMedacta Inernational SA202012—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+6K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+6K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+6K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+6K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K132879Mpact ExtensionMedacta International201411—
+6K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K111145Endo HeadMedacta International20110—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K211891DM Converter - TiN coatedMedacta International S.A.20220—
+7K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+7K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+7K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K202152NextAR TKA PlatformMedacta International S.A.202011—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K250477NextAR (TM) SpineMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+8K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+9K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+9K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+9K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+9K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+9K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—