510(k) Report

Devices descending from K082996

61 later devices reach Biolox Delta Option Ceramic Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+1K131518Mectacer Biolox Option HeadsMedacta International20130—
+1K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+2K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+2K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+3K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+3K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+3K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K261453G7® Acetabular SystemZimmer Biomet20260—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—