510(k) Report

Devices descending from K033995

624 later devices reach 3.5 MM LCP Distal Humerus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+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—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+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—
+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—
+8K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+8K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+8K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242861TrueLok ElevateOrthofix Srl20243—
+9K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—