510(k) Report

Devices descending from K020401

132 later devices reach Synthes Calcaneal Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123