510(k) Report

Devices descending from K000242

62 later devices reach Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070479Exactech Novation Crown Cup and LinersExactech, Inc.20075916
+1K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc.2004611
+2K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+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
+2K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.201053—
+2K100269Novation Crown Cup GXL LinersExactech, Inc.201057
+2K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.20056012
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.201236—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+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—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+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—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+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—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—