510(k) Report

Devices descending from K102537

19 later devices reach Aptus 1.5 Trilock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+1K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+1K232144Sterile Products of the APTUS SystemMedartis AG20233—
+1K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+1K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K260761APTUS Clavicle System 2.8Medartis AG20260—
+2K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+2K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+2K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+2K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K200226RetroFixRetrofix Screws, LLC20200—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—