510(k) Report

Devices descending from K030923

31 later devices reach Epsilon Durasul Constrained Acetabular Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+1K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+1K071718Trilogy Longevity Constrained LinerZimmer, Inc.2007281
+1K040601Exactech Acumatch a-Series & MCS Constrained Acetabular LinersExactech, Inc.200411
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+2K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K103352Versafitcup CC TrioMedacta International20114—
+2K101730Longevity IT Highly Crosslinked Polyethylene Constrained LinersZimmer, Inc.20102—
+2K093561Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc.20100—
+2K071676Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc.200702
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K132879Mpact ExtensionMedacta International201411—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122641Mpact ExtensionMedacta International201214—
+3K111145Endo HeadMedacta International20110—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—