510(k) Report

Devices descending from K093549

60 later devices reach 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+1K131518Mectacer Biolox Option HeadsMedacta International20130—
+1K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+2K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+2K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+2K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+2K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K182099Delta TT ProLima Corporate S.P.A.20183—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—