510(k) Report

Devices descending from K960340

5 later devices reach Consensus Apex Dome Hole Plug through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+2K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+2K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+2K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+2K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—