510(k) Report

Devices descending from K193639

9 later devices reach APTUS® Foot 2.8-3.5 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+1K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+1K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—