510(k) Report

Devices descending from K042355

24 later devices reach Synthes (Usa) LCP Wrist Fusion Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213214Xpert WristNewclip Technics20210—
+1K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+1K172425OrthoPediatrics Wrist Fusion PlateOrthopediatrics, Inc.20170—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC20130—
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+1K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+1K102785Trimed Radiocarpal Fusion SystemTriMed, Inc.20112—
+1K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC20101—
+1K092720Wrist Arthrodesis Nail SystemSkeletal Dynamics, LLC20100—
+1K093163Integra Total Wrist Fusion SystemIntegra LifeSciences Corporation20090—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+2K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+2K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+2K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+3K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+3K232144Sterile Products of the APTUS SystemMedartis AG20233—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+3K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+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—