510(k) Report

Devices descending from K041081

257 later devices reach Fragment Plate System, Screws, Pins and K-Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+6K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K171510Footmotion Plating SystemNewclip Technics20171—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K170012Foot and Hand MotionNewclip Technics20170—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+6K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+6K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+6K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+7K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+7K211843PolyLock Plating SystemFusion Orthopedics20220—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+7K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+7K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+8K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+8K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123