510(k) Report

Devices descending from K002149

244 later devices reach Lineage Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+4K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+4K131952Corin Metafix Hip StemCorin USA20134—
+4K131986Corin Minihip StemCorin USA20133—
+4K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+4K111911Corin Optimom Modular HeadCorin USA201162—
+4K103721Mpact Acetabular SystemMedacta International201121—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K132879Mpact ExtensionMedacta International201411—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K111145Endo HeadMedacta International20110—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K130634Corin Metafix Hip StemCorin USA20135—