510(k) Report

Devices descending from K193554

8 later devices reach APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+1K232144Sterile Products of the APTUS SystemMedartis AG20233—
+1K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—