510(k) Report

Devices descending from K080101

180 later devices reach Aap Cannulated Screw and Darco Headed Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC20161—
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K111316Aap Cannulated ScrewsAap Implantate AG201139—
+1K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc2010145—
+2K233008Cannulated Headless Bone ScrewsAap Implantate AG20240—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+2K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K132893Edge Orthopaedics Bite Compression ScrewIcon Orthopaedic Concepts Dba Edge Orthopaedics20130—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+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—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—