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
+2K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+2K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+2K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+2K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+2K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K210159IntraLock SystemFusion Orthopedics, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+2K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+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—
+2K193029Conquest FNSmith & Nephew, Inc.202010—
+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—
+2K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191—
+2K182677DynaNail MiniMedShape, Inc.20195—
+2K182919SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical20191—
+2K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+2K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+2K173752SI Screw SystemZavation Medical Products, LLC20180—
+2K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+2K172785Conquest FNSmith & Nephew20178—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162171S4 Screw System™Subchondral Solutions20173—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+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—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+2K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+2K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+2K152686Conquest FNSmith & Nephew201612—
+2K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+2K151718iFuse Implant SystemSI-BONE, Inc.201585—
+2K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201542—
+2K150875iFuse Implant SystemSI-BONE, Inc.201586—
+2K151418Monster Screw SystemParagon 28201527—
+2K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+2K141246Life Spine Sacroiliac Joint Fixation SystemLife Spine, Inc.201529—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+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—
+2K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+2K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+2K123850Ifuse Implant SystemSI-BONE, Inc.2013134—
+2K122074Ifuse Implant SystemSI-BONE, Inc.2012139—
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K110838Ifuse Implant SystemSI-BONE, Inc.2011143—
+2K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011241—
+2K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—