510(k) Report

Devices descending from K002149

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710—
+1K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716—
+1K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc.2016611
+1K142119Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc.20159—
+1K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+1K140043Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadMicroport Orthopedics, Inc.201410—
+1K132158Novohip Total Hip SystemNovosource, Inc.201461
+1K060635Consensus Acetabular Shell SystemHayes Medical, Inc.200669—
+1K031110Apex Modular Acetabular CupApex Surgical, LLC2003217—
+2K253066ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc.20260—
+2K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc.20250—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+2K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+2K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.20210—
+2K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.20210—
+2K211677ELEOS Limb Salvage SystemOnkos Surgical20210—
+2K203815ELEOS Limb Salvage System with BioGripOnkos Surgical202103
+2K203588ELEOS™ Limb Salvage SystemOnkos Surgical202103
+2K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical20201—
+2K190123MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.20191—
+2K181598Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc.20181—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.20182—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+2K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+2K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+2K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421—
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+2K112779Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Omnlife Science201121
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+2K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+2K093472Trinity Acetabular SystemCorin USA20101171
+2K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+2K092443Interface Acetabular Cup LinersOmni Life Science, Inc.20091—
+2K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+3K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+3K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+3K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+3K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+3K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+3K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+3K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K142761Corin TaperFit Hip StemCorin USA201541
+3K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+3K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K130128Trinity Acetabular SystemCorin Medical201317—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K121563Corin Trifit TS HipCorin USA2012101
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+3K103518Trinity Acetabular SystemCorin USA20118—
+3K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+3K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+3K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—