510(k) Report

Devices descending from K061748

157 later devices reach Fragment Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K171510Footmotion Plating SystemNewclip Technics20171—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170843Alians Fragment SpecificNewclip Technics20171—
+5K170012Foot and Hand MotionNewclip Technics20170—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+6K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+6K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+6K211843PolyLock Plating SystemFusion Orthopedics20220—
+6K213214Xpert WristNewclip Technics20210—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123