510(k) Report

Devices descending from K101240

154 later devices reach Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170012Foot and Hand MotionNewclip Technics20170—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+5K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241539Activmotion SNewclip Technics20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K211843PolyLock Plating SystemFusion Orthopedics20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K213214Xpert WristNewclip Technics20210—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123