510(k) Report

Devices descending from K100555

34 later devices reach Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+1K103721Mpact Acetabular SystemMedacta International201121—
+1K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+1K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+1K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+2K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+2K250450Coated hip implantsMedacta International S.A.20250—
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K230011Mpact ExtensionMedacta International S.A.20233—
+2K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+2K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+2K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K200391MPACT ExtensionMedacta International S.A.20210—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K132879Mpact ExtensionMedacta International201411—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K122911Versafitcup CC Trio ExtensionMedacta International20121—
+2K122641Mpact ExtensionMedacta International201214—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K111145Endo HeadMedacta International20110—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+4K261576Icona Hip StemCorin, Ltd.20260—