510(k) Report

Devices descending from K993082

161 later devices reach Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+1K141797Alteon 6.5MM Bone ScrewsExactech, Inc.20146—
+1K103352Versafitcup CC TrioMedacta International20114—
+1K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101—
+1K070479Exactech Novation Crown Cup and LinersExactech, Inc.20075916
+1K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.20056012
+1K040601Exactech Acumatch a-Series & MCS Constrained Acetabular LinersExactech, Inc.200411
+1K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041451
+1K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc.2004611
+2K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+2K250450Coated hip implantsMedacta International S.A.20250—
+2K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+2K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+2K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+2K141960Exactech® Novation® Crown Cup®Exactech, Inc.20150—
+2K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+2K122911Versafitcup CC Trio ExtensionMedacta International20121—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+2K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+2K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+2K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+2K080980Exactech Novation Element Press-Fit Femoral StemsExactech, Inc.2008281
+2K071676Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc.200702
+2K051335Acumatch 12/14 Press-Fit Femoral StemsExactech, Inc.20050—
+2K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.200464—
+3K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+3K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc.20165—
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+3K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+3K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+3K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.201236—
+3K113320Novation Element Femoral Stem, 12/14 Collarless Standard/High Offset HA Coated…Exactech, Inc.20120—
+3K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054—
+3K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—
+3K063279Novation Splined RDD Femoral StemsExactech, Inc.200602
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+4K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+4K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+4K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+4K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—