510(k) Report

Devices descending from K964769

363 later devices reach Versys Hip System--Fiber Metal Taper Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+7K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+7K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+7K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+7K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+7K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+7K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+7K143453Mpact Double Mobility SystemMedacta International20151—
+7K132879Mpact ExtensionMedacta International201411—
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+7K131458Mpact DM Liner ConverterMedacta International20133—
+7K123692Pipeline Knee SystemPipeline Orthopedics20130—
+7K122911Versafitcup CC Trio ExtensionMedacta International20121—
+7K122641Mpact ExtensionMedacta International201214—
+7K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+7K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+7K111145Endo HeadMedacta International20110—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+8K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+8K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+8K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+8K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+8K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+8K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+8K221104Actera™ hip systemConformis, Inc.202211
+8K211891DM Converter - TiN coatedMedacta International S.A.20220—
+8K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+8K220405Amis K LongMedacta International S.A.20220—
+8K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+8K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K202152NextAR TKA PlatformMedacta International S.A.202011—
+8K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+8K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+8K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+8K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+8K130634Corin Metafix Hip StemCorin USA20135—
+8K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+9K252067Velora Acetabular SystemRestor3D, Inc.20250—
+9K250477NextAR (TM) SpineMedacta International S.A.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+9K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+9K231178ACTERA™ hip systemConformis, Inc.20230—
+10K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+10K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+10K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+10K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+10K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—