510(k) Report

Devices descending from K131684

9 later devices reach Biolox (R) Delta Ceramic Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+1K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+1K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+1K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+2K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+2K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—