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
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+4K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+4K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+4K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+4K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.2011162
+4K093472Trinity Acetabular SystemCorin USA20101171
+4K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+4K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+4K081023Evolis Total Knee SystemMedacta International S.A.2008781
+4K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+4K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+5K233476Z1 Hip SystemOrchard Medical Development202421
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+5K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+5K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+5K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+5K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+5K142761Corin TaperFit Hip StemCorin USA201541
+5K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K142069GMK ExtensionMedacta International20144—
+5K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K131647Trinity Acetabular SystemCorin USA201322—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K131310GMK Full PE Tibial ComponentsMedacta International20132—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+5K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+5K130128Trinity Acetabular SystemCorin Medical201317—
+5K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+5K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+5K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc.201210—
+5K121563Corin Trifit TS HipCorin USA2012101
+5K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+5K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+5K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+5K121416GMK SphereMedacta International201220—
+5K120790GMK - Line ExtensionMedacta International201211—
+5K113571GMK Resufacing Patella Size 4Medacta International201223—
+5K111283GMK Revision Hybrid LinersMedacta International20110—
+5K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+5K090988GMK Total Knee SystemMedacta International S.A.2009521
+5K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K262057GMK ExtensionMedacta International SA20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K260831Z1 Hip SystemZimmer, Inc.20260—
+6K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K251906Z1 Hip SystemZimmer, Inc.20251—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—