510(k) Report

Devices descending from K000089

41 later devices reach Synthes 4.0 and 5.0 MM Locking Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…Synthes (USA) Products, LLC202072
+1K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…Synthes (USA) Products, LLC202002
+1K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+1K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+1K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)2011172
+2K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K252016Arthrex Humeral NailsArthrex, Inc.20260—
+2K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+2K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes20241—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—