510(k) Report

Devices descending from K094035

79 later devices reach Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+1K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+1K190276Provident II Hip StemStelkast, Inc.20192—
+1K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+1K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+1K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+1K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+1K122773Cross-Over Acetabular Shell & LinerStelkast Company201261
+1K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+1K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+2K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+2K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+2K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+2K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+2K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+2K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+2K201733Provident II Hip StemsGlobus Medical, Inc.20210—
+2K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+2K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+2K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+2K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+2K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+2K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+2K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K202484Cordera Hip SystemConformis, Inc.202022
+3K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+3K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+3K192198Conformis Hip SystemConformis, Inc.2019121
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—