510(k) Report

Devices descending from K041860

654 later devices reach Synthes (Usa) LCP Proximal Humerus Plates, Long through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K221395Footmotion Plating SystemNewclip Technics20220—
+7K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+7K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203381Dynanail Mini HybridMedShape, Inc.202141
+7K202810AutoStrut G2Orthospin, Ltd.20213—
+7K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+7K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K193366T2 ICFStryker GmbH20201—
+7K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+7K190830TDM Screw SystemsTdm Co., Ltd.20191—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173641Activ AnkleNewclip Technics20183—
+7K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170771VariAx 2 Foot SystemStryker GmbH20170—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+7K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+7K151769Anchorage 2 CP SystemStryker GmbH20150—
+7K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+7K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K262344Large Compression ScrewsTriMed, Inc.20260—
+8K261511Xpert AnkleNewclip Technics20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K261241TriMed Compression ScrewsTriMed, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+8K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+8K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+8K231860TDM Screw SystemTdm Co., Ltd.20240—
+8K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+8K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+8K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+8K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+8K191009Arsenal Plating SystemTrilliant Surgical20192—
+8K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—