510(k) Report

Devices descending from K111025

5 later devices reach Trigen Low Profile Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+1K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+1K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc.20160—
+1K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+1K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201