510(k) Report

Devices descending from K041906

145 later devices reach Exactech 12/14 Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+1K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+1K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101—
+1K080980Exactech Novation Element Press-Fit Femoral StemsExactech, Inc.2008281
+1K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.20056012
+1K051335Acumatch 12/14 Press-Fit Femoral StemsExactech, Inc.20050—
+1K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.200464—
+2K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+2K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+2K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc.20165—
+2K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+2K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+2K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+2K113320Novation Element Femoral Stem, 12/14 Collarless Standard/High Offset HA Coated…Exactech, Inc.20120—
+2K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054—
+2K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+2K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—
+2K070479Exactech Novation Crown Cup and LinersExactech, Inc.20075916
+2K063279Novation Splined RDD Femoral StemsExactech, Inc.200602
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K202484Cordera Hip SystemConformis, Inc.202022
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K192198Conformis Hip SystemConformis, Inc.2019121
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K141960Exactech® Novation® Crown Cup®Exactech, Inc.20150—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+3K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+3K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K243839Alteon® HA Femoral StemsExactech, Inc.20250—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+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—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+4K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.201236—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—