510(k) Report

Devices descending from K090692

170 later devices reach Ortholoc 2.0/2.4 Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K202307Activ FuseNewclip Technics20200—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—