510(k) Report

Devices descending from K002996

203 later devices reach Synergy HA Coated Porous Femoral Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+5K141960Exactech® Novation® Crown Cup®Exactech, Inc.20150—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+5K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+5K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K243839Alteon® HA Femoral StemsExactech, Inc.20250—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+6K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+6K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+6K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.201236—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+7K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+7K243809Biolox® Delta Revision headsLimacorporate20250—
+7K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+7K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+7K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+7K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+7K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+7K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+7K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K182099Delta TT ProLima Corporate S.P.A.20183—
+7K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+7K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+7K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+7K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+7K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+7K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+8K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+8K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+8K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+8K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+8K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+8K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+8K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+8K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+8K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+8K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+8K170473C2 femoral stemLima Corporate S.P.A.20170—
+8K160011H-Max S stemLima Corporate S.P.A.20161—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+9K243247Persona the Personalized Knee SystemZimmer, Inc.20240—