510(k) Report

Devices descending from K040542

3 later devices reach Smith & Nephew GTS Sleeve and GTS Tapered Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+1K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+2K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—