510(k) Report

Devices descending from K921308

472 later devices reach HG Multilock Hip Prosthesis W/ TI-Nidium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231037MyKnee UNI-STMedacta International S.A.20230—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+8K200391MPACT ExtensionMedacta International S.A.20210—
+8K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+8K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+8K202730Quadra-PMedacta International S.A.20201—
+8K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+8K193559NextAR TKA PlatformMedacta Inernational SA202012—
+8K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+8K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K191831MobiliT CupCorin U.S.A. Limited20203—
+8K192827Quadra-PMedacta International S.A.20206—
+8K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+8K183582MPACT ExtensionMedacta International S.A.20194—
+8K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+8K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+8K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+8K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+8K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+8K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+8K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+8K143453Mpact Double Mobility SystemMedacta International20151—
+8K132879Mpact ExtensionMedacta International201411—
+8K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+8K131458Mpact DM Liner ConverterMedacta International20133—
+8K123692Pipeline Knee SystemPipeline Orthopedics20130—
+8K122911Versafitcup CC Trio ExtensionMedacta International20121—
+8K122641Mpact ExtensionMedacta International201214—
+8K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+8K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+8K111145Endo HeadMedacta International20110—
+9K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+9K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+9K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+9K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+9K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+9K211891DM Converter - TiN coatedMedacta International S.A.20220—
+9K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+9K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+9K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K210153NextAR RSA PlatformMedacta International S.A.202151
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K202152NextAR TKA PlatformMedacta International S.A.202011—
+9K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+9K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+9K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+9K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+9K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+9K130634Corin Metafix Hip StemCorin USA20135—
+9K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+10K250477NextAR (TM) SpineMedacta International S.A.20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+10K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+10K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+10K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+11K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+11K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+11K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+11K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+11K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—