510(k) Report

Devices descending from K062489

63 later devices reach Apex Hcla Acetabular Cup Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+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—
+2K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+2K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+2K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+2K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+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—
+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
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+3K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+3K103721Mpact Acetabular SystemMedacta International201121—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111145Endo HeadMedacta International20110—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—