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
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K211664GMK Sphere RevisionMedacta International S.A.20210—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+6K210062Mectaplug PE IIMedacta International S.A.20210—
+6K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K192126AMIStem-P Short NeckMedacta International S.A.20191—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K181254Quadra PMedacta International S.A.20187—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+6K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K162035GMK SphereMedacta International S.A.201710—
+6K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K140826GMK Sphere ExtensionMedacta International201417—
+6K133630GMK Short StemMedacta International20131—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K123721GMK Revision ExtensionMedacta International20133—
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K122232GMK NarrowMedacta International20128—
+6K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+6K111911Corin Optimom Modular HeadCorin USA201162—
+6K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+6K103721Mpact Acetabular SystemMedacta International201121—
+6K103352Versafitcup CC TrioMedacta International20114—
+6K102437GMK Revision Knee SystemMedacta International S.A.201034—
+6K093806Myknee Cutting BlocksMedacta International S.A.201016—
+7K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K241461Mpact Constrained LinerMedacta International S.A.20251—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K230011Mpact ExtensionMedacta International S.A.20233—
+7K231037MyKnee UNI-STMedacta International S.A.20230—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+7K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+7K211703Insignia Hip StemStryker Orthopaedics20217—
+7K211866Bencox THR SystemCorentec Co., Ltd.20210—
+7K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+7K200391MPACT ExtensionMedacta International S.A.20210—
+7K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K202730Quadra-PMedacta International S.A.20201—
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193559NextAR TKA PlatformMedacta Inernational SA202012—
+7K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+7K191831MobiliT CupCorin U.S.A. Limited20203—
+7K192827Quadra-PMedacta International S.A.20206—