510(k) Report

Devices descending from K970501

509 later devices reach Pegged Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company201179—
+1K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20035053
+1K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc.20024801
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K190276Provident II Hip StemStelkast, Inc.20192—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+2K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+2K122773Cross-Over Acetabular Shell & LinerStelkast Company201261
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+2K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+2K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc.200738—
+2K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+2K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005289—
+2K042989RX90 Low Profile Acetabular SystemBiomet, Inc.20051—
+2K042051Arcomxl Polyethylene LinersBiomet, Inc.20053551
+3K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+3K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+3K201733Provident II Hip StemsGlobus Medical, Inc.20210—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+3K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+3K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+3K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165—
+3K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286—
+3K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.20050—
+3K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—