510(k) Report

Devices descending from K952272

194 later devices reach TI. Alloy 2.0 MM Cortex Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc.201113515
+1K011946The Spin Snap-Off ScrewNew Deal, S.A.20016—
+1K962233Twist-Off ScrewLandos, Inc.199692—
+2K253108VEOFIX Snap Off ScrewSteps Ortho20260—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie20170—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+2K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+2K140508Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc.201414—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K070039Memometal Fixos ScrewsMemometal Technologies200784—
+2K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH20052—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K211628MIS Precision Chevron Bunion SystemRelja Innovations, LLC20221—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151418Monster Screw SystemParagon 28201527—
+3K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc.20154—
+3K150121Zimmer Periarticular Plating SystemZimmer, Inc.201509
+3K143146Nexis osteosynthesis snap-off screwsNovastep20152—
+3K143229Nexis osteosynthesis compressive screwsNovastep20153—
+3K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Zimmer, Inc.201412—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+4K262075Lapidus Screw KitRelja Innovations, LLC20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+4K223468Nexis® compressive screwsNovastep20230—
+4K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.20230—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+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
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc.20150—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K141401Easy OutFeet For Life Podiatry Center20150—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+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—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+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—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+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—