510(k) Report

Devices descending from K962011

738 later devices reach Synthes 7.0/7.3 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+1K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+1K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+1K170021SMV Scientific Cannulated ScrewsSmv Scientific20178—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K142776Flow-ScrewFlow-Fx, LLC20151—
+1K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+1K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+1K131920Stabilization ScrewIn2bones Sas2014183
+1K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+1K112240Dyna Locking Cannulated ScrewU&I Corp.201214—
+1K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+1K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical2010220—
+1K102903Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc.2010309—
+1K093676Omnitech Large, Trimed Compression ScrewTriMed, Inc.201013—
+1K092754Sbi Foot and Ankle Cannulated Screw System, Model 100-0061Small Bone Innovations, Inc.20104—
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+1K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+1K021233Aap Cannulated ScrewsAap Implantate AG2002181—
+1K972217Orthopedic Screw SystemFerguson Medical19970—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+2K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K200259Headless Compression Screw SystemOsteocentric Extremities, LLC20200—
+2K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+2K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191—
+2K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+2K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162171S4 Screw System™Subchondral Solutions20173—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+2K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+2K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+2K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+2K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+2K151418Monster Screw SystemParagon 28201527—
+2K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+2K141106Frontier Devices Fusio Screw Fuze SystemFolsom Metal Products, Inc. Dba Frontier Devices20143—
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+2K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+2K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—