510(k) Report

Devices descending from K033618

30 later devices reach Synthes (Usa) Retrograde/Antegrade Femoral Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes20241—
+1K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…Synthes (USA) Products, LLC202072
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+1K091309Revolution Femoral Intramedullary Nail System, Model DgooxxDgimed Ortho, Inc.20091—
+2K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K100312Distalock Femoral Intramedullary Nail SystemDgimed Ortho, Inc.20100—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K163589SIGN IM NailSign Fracture Care International20170—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123