510(k) Report

Devices descending from K011458

11 later devices reach Synthes Straight Wrist Fusion Plate, 170MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC20130—
+1K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+1K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC20101—
+2K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+3K232144Sterile Products of the APTUS SystemMedartis AG20233—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—