510(k) Report

Devices descending from K021932

755 later devices reach Synthes 6.5 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252322SIros-X SystemGenesys Spine20250—
+1K250647SImmetry+ SystemSivantage20250—
+1K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+1K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+1K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+1K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+1K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+1K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+1K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+1K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+1K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+1K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+1K210146Cannulated Compression Device SystemOrthopedic Designs North America, Inc.20220—
+1K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+1K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+1K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+1K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+1K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+1K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+1K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+1K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+1K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.20183—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+1K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+1K170021SMV Scientific Cannulated ScrewsSmv Scientific20178—
+1K170475SICAGE™ SystemSicage, LLC20170—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K162121Siconus SI Joint Fixation SystemCamber Spine Technologies20171—
+1K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+1K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+1K152757SIGN Hip Construct (SHC)Sign Fracture Care International20150—
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K151462SI-Technology® SI-Desis® ScrewsSi-Technology, LLC20155—
+1K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201563—
+1K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+1K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+1K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+1K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+1K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+1K123702Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201349—
+1K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+1K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+1K112240Dyna Locking Cannulated ScrewU&I Corp.201214—
+1K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+1K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010245—
+1K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical2010220—
+1K102903Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc.2010309—
+1K092754Sbi Foot and Ankle Cannulated Screw System, Model 100-0061Small Bone Innovations, Inc.20104—
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+1K080398SI Joint Fusion SystemSI-BONE, Inc.2008144—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+1K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH200512—
+1K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+2K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+2K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+2K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K230817TORPEDO Implant System®Deltacor GmbH20240—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+2K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+2K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+2K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+2K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+2K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+2K213815SiJoin®T3Vgi Medical, Inc.20230—
+2K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+2K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+2K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+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—