510(k) Report

Devices descending from K954330

464 later devices reach Super Screw 3.5 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193366T2 ICFStryker GmbH20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K153378Monster BITE Screw SystemParagon 28201522—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154—
+5K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+5K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+6K254280F.A.S.T ScrewSteps Ortho20260—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—