510(k) Report

Devices descending from K063278

40 later devices reach Portland Cobalt Chrome Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotMedacta International S.A.2008391
+2K121011Amistem and Quadra - Line ExtensionMedacta International201210—
+2K111145Endo HeadMedacta International20110—
+2K093944Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A.2010121
+2K083558Medacta Total Hip Prosthesis System - Quadra CMedacta International S.A.200991
+2K082792Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsMedacta International S.A.2008111
+2K080885Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A.200822—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K220405Amis K LongMedacta International S.A.20220—
+3K192827Quadra-PMedacta International S.A.20206—
+3K181254Quadra PMedacta International S.A.20187—
+3K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+3K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103189Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short NeckMedacta International S.A.201011
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K251166Mfinity Femoral SystemMedacta International S.A.20250—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K202730Quadra-PMedacta International S.A.20201—
+4K203041SMS Cementless StemMedacta International S.A.20201—
+4K193433AMIStem-CMedacta International S.A.20200—
+4K192126AMIStem-P Short NeckMedacta International S.A.20191—
+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—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—