510(k) Report

Devices descending from K161616

33 later devices reach DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+1K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+1K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+1K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+1K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+1K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+1K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+1K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+1K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+1K211435PAO Cortical ScrewMedacta International S.A.20210—
+1K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+1K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+1K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+1K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+1K190830TDM Screw SystemsTdm Co., Ltd.20191—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K262344Large Compression ScrewsTriMed, Inc.20260—
+2K261241TriMed Compression ScrewsTriMed, Inc.20260—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+2K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+2K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+2K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+2K231860TDM Screw SystemTdm Co., Ltd.20240—
+2K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+2K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—