510(k) Report

Devices descending from K091479

51 later devices reach Aptus Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+1K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+1K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K142581APTUS Foot SystemMedartis AG201522—
+1K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+1K110908Aptus Foot 3.5 SystemMedartis AG201125—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K201656ARIX Elbow SystemJeil Medical Corporation20200—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K191636APTUS Foot SystemMedartis AG20190—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—