510(k) Report

Devices descending from K101575

24 later devices reach Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+1K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+1K103721Mpact Acetabular SystemMedacta International201121—
+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—
+2K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+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—
+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—
+3K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+3K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—