510(k) Report

Devices descending from K982953

121 later devices reach Titanium Intramedullary Nails-Various Styles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K163589SIGN IM NailSign Fracture Care International20170—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+5K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+5K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—