510(k) Report

Devices descending from K071830

14 later devices reach Depuy Delta TS Ceramic Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K073567Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH200871
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+2K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+2K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+2K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+2K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+3K200112Zimmer Hip Joint ReplacementZimmer GmbH202002