510(k) Report

Devices descending from K053105

31 later devices reach Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC20171—
+1K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.200810—
+1K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)200814—
+1K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)200829—
+2K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp.20211—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K201961IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc.20202—
+2K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILOrthofix Srl20170—
+2K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160—
+2K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.201561
+2K143276Acumed Small Bone IM Nail SystemAcumed, LLC201510—
+3K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.20250—
+3K250559GMReis Fibula Nail SystemGm Dos Reis Industria E Comercio20250—
+3K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+3K202887IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.20201—
+3K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.20205—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171—
+4K250197Estremo Fibular NailCitieffe S.R.L.20250—
+4K241983Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical20250—
+4K234128Phantom Fibula Nail SystemParagon 28, Inc.202401
+4K233436IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc.20240—
+4K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+4K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+5K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+5K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+5K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+6K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—