510(k) Report

Devices descending from K915316

182 later devices reach Aap Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021233Aap Cannulated ScrewsAap Implantate AG2002181—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K111316Aap Cannulated ScrewsAap Implantate AG201139—
+2K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG2008180—
+3K233008Cannulated Headless Bone ScrewsAap Implantate AG20240—
+3K211435PAO Cortical ScrewMedacta International S.A.20210—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC20161—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc2010145—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K132893Edge Orthopaedics Bite Compression ScrewIcon Orthopaedic Concepts Dba Edge Orthopaedics20130—
+4K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+5K151407RECON systemNormed Medizin-Technik GmbH20154—
+5K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+5K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+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—
+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—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+6K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+6K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+6K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+6K143365Eminent Foot Plate SystemEminent Spine20151—
+6K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+7K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320