510(k) Report

Devices descending from K993762

338 later devices reach I.CO.S Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081934Extremity Medical Compression ScrewExtremity Medical, LLC200868—
+1K024233Kompressor Screw SystemKinetikos Medical, Inc.2003299—
+1K011821Modification to the I.C.O.S ScrewNew Deal, S.A.200156—
+2K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+2K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+2K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+2K050346Stabilization ScrewNew Deal, S.A.2005554
+2K040356Kompressor Screw SystemKinetikos Medical, Inc.2004255—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K160617Large Screws RangeNewclip Technics20166—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K131920Stabilization ScrewIn2bones Sas2014183
+3K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc.20132—
+3K130954Ars Screw; Slant ScrewAdvanced Interventional Technology, LLC20130—
+3K121417XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC20122—
+3K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC201212—
+3K093770Extremity Medical Screw SystemExtremity Medical, LLC20103—
+3K091798Merete Compression ScrewsMerete Medical GmbH200926—
+3K091577Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw SystemExtremity Medical, LLC20094—
+3K071639Qwix Positioning ScrewNewdeal Sas2007521
+3K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006251—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+4K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K172596Large Screws RangeNewclip Technics20174—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+4K170012Foot and Hand MotionNewclip Technics20170—
+4K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+4K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+4K140875Optossol Compression Device SystemGenossis, LLC20140—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+4K073159Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd.20083—
+4K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K173641Activ AnkleNewclip Technics20183—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+5K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+5K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+5K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+5K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+5K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+5K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+5K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+5K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—