510(k) Report

Devices descending from K121651

95 later devices reach Ortholoc 3DI Midfoot/Flatfoot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221395Footmotion Plating SystemNewclip Technics20220—
+1K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+1K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K161448Footmotion Plating SystemNewclip Technics20165—
+1K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+1K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+1K151407RECON systemNormed Medizin-Technik GmbH20154—
+1K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+1K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+1K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+1K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+2K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+2K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+2K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+2K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+2K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K171510Footmotion Plating SystemNewclip Technics20171—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K170012Foot and Hand MotionNewclip Technics20170—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+3K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K211843PolyLock Plating SystemFusion Orthopedics20220—
+3K213214Xpert WristNewclip Technics20210—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—