510(k) Report

Devices descending from K895241

8 later devices reach Intramedullary Hip Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+1K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+1K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042—
+2K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+2K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.20111—
+3K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—