510(k) Report

Devices descending from K990197

164 later devices reach Modulus Compatible Stability (MCS)-HA Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080980Exactech Novation Element Press-Fit Femoral StemsExactech, Inc.2008281
+1K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc.2004611
+1K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003146—
+1K002141Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series…Exactech, Inc.2000147—
+1K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentExactech, Inc.19991612
+2K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+2K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc.20165—
+2K141797Alteon 6.5MM Bone ScrewsExactech, Inc.20146—
+2K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+2K113320Novation Element Femoral Stem, 12/14 Collarless Standard/High Offset HA Coated…Exactech, Inc.20120—
+2K103352Versafitcup CC TrioMedacta International20114—
+2K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp.20101—
+2K070479Exactech Novation Crown Cup and LinersExactech, Inc.20075916
+2K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.20056012
+2K040601Exactech Acumatch a-Series & MCS Constrained Acetabular LinersExactech, Inc.200411
+2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041451
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K250450Coated hip implantsMedacta International S.A.20250—
+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—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+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—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+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—
+3K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+3K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+3K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+3K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc.20100—
+3K071676Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc.200702
+3K051335Acumatch 12/14 Press-Fit Femoral StemsExactech, Inc.20050—
+3K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.200464—
+4K243839Alteon® HA Femoral StemsExactech, Inc.20250—
+4K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+4K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+4K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.201236—
+4K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054—
+4K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—
+4K063279Novation Splined RDD Femoral StemsExactech, Inc.200602
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+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—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—