510(k) Report

Devices descending from K963420

339 later devices reach Cancellous Screw Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011821Modification to the I.C.O.S ScrewNew Deal, S.A.200156—
+1K993762I.CO.S ScrewNew Deal, S.A.2000338—
+2K081934Extremity Medical Compression ScrewExtremity Medical, LLC200868—
+2K050346Stabilization ScrewNew Deal, S.A.2005554
+2K024233Kompressor Screw SystemKinetikos Medical, Inc.2003299—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+3K160617Large Screws RangeNewclip Technics20166—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+3K131920Stabilization ScrewIn2bones Sas2014183
+3K130954Ars Screw; Slant ScrewAdvanced Interventional Technology, LLC20130—
+3K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+3K091798Merete Compression ScrewsMerete Medical GmbH200926—
+3K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+3K071639Qwix Positioning ScrewNewdeal Sas2007521
+3K040356Kompressor Screw SystemKinetikos Medical, Inc.2004255—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K172596Large Screws RangeNewclip Technics20174—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+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—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc.20132—
+4K121417XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC20122—
+4K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC201212—
+4K093770Extremity Medical Screw SystemExtremity Medical, LLC20103—
+4K091577Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw SystemExtremity Medical, LLC20094—
+4K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006251—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K173641Activ AnkleNewclip Technics20183—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+5K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K140875Optossol Compression Device SystemGenossis, LLC20140—
+5K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+5K073159Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd.20083—
+5K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+6K213214Xpert WristNewclip Technics20210—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+6K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—