510(k) Report

Devices descending from K002775

719 later devices reach Distal Volar Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+11K223558CUVIS-spineCurexo, Inc.20230—
+11K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+11K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+11K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+11K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+11K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+11K221395Footmotion Plating SystemNewclip Technics20220—
+11K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+11K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+11K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+11K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+11K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+11K201569CUVIS-spineCurexo, Inc.20212—
+11K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+11K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+11K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+11K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+11K203381Dynanail Mini HybridMedShape, Inc.202141
+11K202810AutoStrut G2Orthospin, Ltd.20213—
+11K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+11K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+11K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+11K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+11K193366T2 ICFStryker GmbH20201—
+11K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+11K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+11K190830TDM Screw SystemsTdm Co., Ltd.20191—
+11K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+11K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+11K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+11K173641Activ AnkleNewclip Technics20183—
+11K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+11K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+11K170771VariAx 2 Foot SystemStryker GmbH20170—
+11K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+11K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+11K151769Anchorage 2 CP SystemStryker GmbH20150—
+11K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+11K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+12K262344Large Compression ScrewsTriMed, Inc.20260—
+12K261511Xpert AnkleNewclip Technics20260—
+12K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+12K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+12K261241TriMed Compression ScrewsTriMed, Inc.20260—
+12K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+12K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+12K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+12K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+12K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+12K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+12K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+12K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+12K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+12K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+12K233256Robotic Integration InstrumentsDePuy Synthes20240—
+12K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+12K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+12K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+12K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+12K231860TDM Screw SystemTdm Co., Ltd.20240—
+12K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+12K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+12K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+12K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+12K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+12K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+12K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+12K222698CUVIS-spineCurexo, Inc.20220—
+12K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+12K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+12K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+12K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+12K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+12K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+12K191009Arsenal Plating SystemTrilliant Surgical20192—
+12K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+12K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+12K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+13K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+13K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+13K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+13K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+13K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+13K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+13K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+13K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+13K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+13K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+13K242861TrueLok ElevateOrthofix Srl20243—
+13K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+13K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+13K241846E3D™-C Interbody SystemEvolution Spine20246—
+13K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+13K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+13K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+13K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+13K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+13K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—