510(k) Report

Devices descending from K043583

191 later devices reach Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+1K163038EPIC Extremity Snap-Off ScrewEpic Extremity, LLC20170—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K133713Charlotte (TM) Snap-Off ScrewWrightmedicaltechnologyinc201483—
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+1K053394Nexa Bone Screw SystemNexa Orthopedics, Inc.20059—
+1K050819Charlotte Snap-Off ScrewWrightmedicaltechnologyinc2005178—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K210159IntraLock SystemFusion Orthopedics, LLC20210—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.20170—
+2K170642GRAVITY™ Soft Tissue Repair SystemWrightmedicaltechnologyinc20170—
+2K170782Medline UNITE® Snap-Off ScrewsMedline Industries, Inc.20170—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150871ForeFoot STP SystemTornier, Inc.20150—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+2K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+2K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+2K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+2K120390Solafix Twist Screw Implant System, Surgical Instrument SetSolana Surgical, LLC20120—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+2K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc.20065—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+3K172205ExoToe StapleExotoe, LLC20180—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+3K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K210456Ligament StapleMedacta International S.A.20210—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+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
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501