510(k) Report

Devices descending from K024233

299 later devices reach Kompressor Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+1K081934Extremity Medical Compression ScrewExtremity Medical, LLC200868—
+1K040356Kompressor Screw SystemKinetikos Medical, Inc.2004255—
+2K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc.20132—
+2K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+2K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+2K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006251—
+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—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K140875Optossol Compression Device SystemGenossis, LLC20140—
+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—
+3K091577Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw SystemExtremity Medical, LLC20094—
+3K073159Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd.20083—
+3K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+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—
+4K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+4K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+4K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+4K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+4K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+4K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+4K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+4K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+5K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+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—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+5K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+5K202326BESPA Charcot SystemBespa Global, LLC20210—
+5K210159IntraLock SystemFusion Orthopedics, LLC20210—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+5K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+5K193029Conquest FNSmith & Nephew, Inc.202010—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+5K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172785Conquest FNSmith & Nephew20178—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+5K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+5K152686Conquest FNSmith & Nephew201612—
+5K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+5K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+5K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+5K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+5K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+5K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+5K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+5K133460Aptus Cannulated Compression ScrewsMedartis AG20138—