510(k) Report

Devices descending from K111253

135 later devices reach Arthrex Distal Extremity Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—