510(k) Report

Devices descending from K080850

17 later devices reach Darco Headless Compression Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223468Nexis® compressive screwsNovastep20230—
+1K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+1K133451Fixos Screw SystemStryker Trauma AG20143—
+1K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+1K132893Edge Orthopaedics Bite Compression ScrewIcon Orthopaedic Concepts Dba Edge Orthopaedics20130—
+2K262075Lapidus Screw KitRelja Innovations, LLC20260—
+2K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+2K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—