510(k) Report

Devices descending from K933281

553 later devices reach S.O.S. Proximal Femur through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K003182Orthogenesis LPS SystemDepuy, Inc.200163—
+1K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998508—
+2K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+2K211677ELEOS Limb Salvage SystemOnkos Surgical20210—
+2K081860Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary SegmentsZimmer, Inc.200811
+2K063686Depuy LPS Distal Femoral ComponentDePuy Orthopaedics, Inc.20070—
+2K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc.20072Class I
+2K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc.20040Class I
+2K040281LPS Metaphyseal Sleeve (Limb Preservation System)DePuy Orthopaedics, Inc.200454—
+2K033959LPSDepuy, Inc.20043—
+2K033871IM Total FemurBiomet, Inc.20041—
+2K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20035053
+3K202248Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC20201—
+3K192798Zimmer Segmental SystemZimmer, Inc.20200—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+3K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company201179—
+3K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+3K063633Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc.2007311
+3K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc.200738—
+3K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+3K062301Depuy LPS Proximal Tibial ComponentDePuy Orthopaedics, Inc.20060—
+3K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.200636—
+3K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005289—
+3K042051Arcomxl Polyethylene LinersBiomet, Inc.20053551
+4K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+4K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190276Provident II Hip StemStelkast, Inc.20192—
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+4K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+4K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+4K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+4K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+4K122773Cross-Over Acetabular Shell & LinerStelkast Company201261
+4K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+4K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+4K110404Eaum Total Knee SystemCorentec Co., Ltd.2012142
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+4K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165—
+4K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286—
+4K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+5K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+5K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K201733Provident II Hip StemsGlobus Medical, Inc.20210—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+5K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+5K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—