510(k) Report

Devices descending from K963798

756 later devices reach Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+12K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+12K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+12K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+12K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+12K240160EGPS Navigated InstrumentsAstura Medical20240—
+12K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+12K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+12K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+12K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+12K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+12K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+12K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+12K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+12K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+12K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+12K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+12K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+12K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+12K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+12K223558CUVIS-spineCurexo, Inc.20230—
+12K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+12K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+12K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+12K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+12K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+12K221395Footmotion Plating SystemNewclip Technics20220—
+12K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+12K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+12K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+12K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+12K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+12K201569CUVIS-spineCurexo, Inc.20212—
+12K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+12K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+12K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+12K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+12K203381Dynanail Mini HybridMedShape, Inc.202141
+12K202810AutoStrut G2Orthospin, Ltd.20213—
+12K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+12K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+12K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+12K193366T2 ICFStryker GmbH20201—
+12K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+12K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+12K190830TDM Screw SystemsTdm Co., Ltd.20191—
+12K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+12K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+12K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+12K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+12K173641Activ AnkleNewclip Technics20183—
+12K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+12K172886Breakaway Screw SystemParagon 2820174—
+12K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+12K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+12K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+12K170771VariAx 2 Foot SystemStryker GmbH20170—
+12K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+12K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+12K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+12K151769Anchorage 2 CP SystemStryker GmbH20150—
+12K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+12K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+13K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+13K262344Large Compression ScrewsTriMed, Inc.20260—
+13K261511Xpert AnkleNewclip Technics20260—
+13K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+13K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+13K261241TriMed Compression ScrewsTriMed, Inc.20260—
+13K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+13K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+13K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+13K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+13K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+13K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+13K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+13K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+13K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+13K233256Robotic Integration InstrumentsDePuy Synthes20240—
+13K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+13K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+13K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+13K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+13K231860TDM Screw SystemTdm Co., Ltd.20240—
+13K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+13K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+13K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+13K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+13K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+13K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+13K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+13K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+13K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+13K222698CUVIS-spineCurexo, Inc.20220—
+13K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+13K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+13K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+13K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+13K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—