510(k) Report

Devices descending from K915818

230 later devices reach Synthes (R) Titanium Small Reconstruction Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+7K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+7K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+8K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+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—
+8K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123