510(k) Report

Devices descending from K050110

142 later devices reach Synthes (Usa) LCP Modular Foot Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+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—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—