510(k) Report

Devices descending from K111041

77 later devices reach Mini Variable System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+1K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+2K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+3K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K191867ATLAS Plating SystemMiRus, LLC20200—
+3K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+4K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+4K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—