510(k) Report

Devices descending from K931641

173 later devices reach Porocoat Porous Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K014070Epoch Hip Prosthesis, Model 4075 SeriesZimmer, Inc.20022—
+1K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001158—
+1K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001159—
+1K000207Porocoat Prodigy Hip ProsthesisDePuy Orthopaedics, Inc.20000—
+1K973714Versys Hip System Beaded Hip ProsthesisZimmer, Inc.1997188
+2K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp20080—
+2K061833Depuy Aml Hip ProsthesisDePuy Orthopaedics, Inc.20060—
+2K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+2K052321Versys Epoch Fullcoat Hip ProsthesisZimmer, Inc.20061—
+2K042776Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XXZimmer, Inc.2004111
+2K030979Modification to Depuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc.200310—
+2K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003146—
+2K030079Versys Beaded Fullcoat Bowed Revision Hip ProsthesisZimmer, Inc.200315
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+3K073499Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc.20080—
+3K061786Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisZimmer, Inc.200610—
+3K060581Depuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc.2006920
+3K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041451
+3K033034Versys Beaded Fullcoat Calcar Hip ProsthesisZimmer, Inc.200301
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+4K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+4K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+4K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101—
+4K080980Exactech Novation Element Press-Fit Femoral StemsExactech, Inc.2008281
+4K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.20056012
+4K051335Acumatch 12/14 Press-Fit Femoral StemsExactech, Inc.20050—
+4K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.200464—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+5K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc.20165—
+5K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+5K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+5K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+5K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+5K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+5K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+5K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K113320Novation Element Femoral Stem, 12/14 Collarless Standard/High Offset HA Coated…Exactech, Inc.20120—
+5K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054—
+5K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+5K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—
+5K070479Exactech Novation Crown Cup and LinersExactech, Inc.20075916
+5K063279Novation Splined RDD Femoral StemsExactech, Inc.200602
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+6K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+6K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+6K202484Cordera Hip SystemConformis, Inc.202022
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192198Conformis Hip SystemConformis, Inc.2019121
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+6K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+6K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+6K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+6K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+6K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+6K141960Exactech® Novation® Crown Cup®Exactech, Inc.20150—
+6K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+6K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+6K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+6K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+7K243839Alteon® HA Femoral StemsExactech, Inc.20250—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+7K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—