510(k) Report

Devices descending from K030055

208 later devices reach Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation20133—
+4K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+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—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+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—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K243809Biolox® Delta Revision headsLimacorporate20250—