510(k) Report

Devices descending from K031110

217 later devices reach Apex Modular Acetabular Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+1K112779Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Omnlife Science201121
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+1K093472Trinity Acetabular SystemCorin USA20101171
+1K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+1K092443Interface Acetabular Cup LinersOmni Life Science, Inc.20091—
+1K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.200862—
+1K060635Consensus Acetabular Shell SystemHayes Medical, Inc.200669—
+2K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+2K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+2K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+2K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+2K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+2K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+2K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+2K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+2K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+2K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc.201421—
+2K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K131647Trinity Acetabular SystemCorin USA201322—
+2K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+2K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+2K130128Trinity Acetabular SystemCorin Medical201317—
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+2K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+2K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+2K121563Corin Trifit TS HipCorin USA2012101
+2K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+2K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+2K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+2K103518Trinity Acetabular SystemCorin USA20118—
+2K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+2K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+2K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+2K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+3K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+3K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+3K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+3K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+3K131952Corin Metafix Hip StemCorin USA20134—
+3K131986Corin Minihip StemCorin USA20133—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+3K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+3K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+3K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+3K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+3K111911Corin Optimom Modular HeadCorin USA201162—
+3K103721Mpact Acetabular SystemMedacta International201121—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—