510(k) Report

Devices descending from K954330

464 later devices reach Super Screw 3.5 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K150871ForeFoot STP SystemTornier, Inc.20150—
+4K151146N-Force Fixation SystemInnovision, Inc.20151—
+4K151418Monster Screw SystemParagon 28201527—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K142776Flow-ScrewFlow-Fx, LLC20151—
+4K143139Arthrex Fracture SystemArthrex, Inc.20151—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+4K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420—
+4K132244N-Force Fixation SystemInnovision, Inc.20143—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+4K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.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—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203381Dynanail Mini HybridMedShape, Inc.202141
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K203011Monster Screw SystemParagon 28, Inc.20206—