510(k) Report

Devices descending from K991197

114 later devices reach Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—