510(k) Report

Devices descending from K062066

5 later devices reach Omega 3 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+1K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+1K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+1K172872DePuy Synthes Femoral Neck SystemDePuy Synthes20182—
+2K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—