510(k) Report

Devices descending from K042842

64 later devices reach Novation 12/14 Press-Fit Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+1K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+1K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+1K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054—
+1K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—
+1K063279Novation Splined RDD Femoral StemsExactech, Inc.200602
+2K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+2K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+2K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+2K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K202484Cordera Hip SystemConformis, Inc.202022
+3K192198Conformis Hip SystemConformis, Inc.2019121
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+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—