510(k) Report

Devices descending from K042365

35 later devices reach Synthes (Usa) Neuro Plate and Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200—
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K123723Synthes Matrixneuro Cranial Plating SystemSynthes20132—
+1K091686Leforte Neurosystem Bone ScrewJeil Medical Corporation200929—
+1K091679Leforte System Bone PlateJeil Medical Corporation200929—
+2K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+2K140462Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)Synthes (USA) Products, LLC20141—
+2K112457Leforte System Bone Plate & ScrewArkin Consulting Group201216—
+2K112812Leforte Neuro System Bone PlateJeil Medical Corporation201211—
+3K252246Leforte MMF SystemJeil Medical Corporation20260—
+3K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+3K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+3K170368Sterile NS SystemJeil Medical Corporation20170—
+3K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+3K150965LeForte System IIJeil Medical Corporation20151—
+3K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+3K141644Innovasis Cranial SystemInnovasis, Inc.20140—
+3K141452Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation20144—
+3K131311Arix Foot SystemJeil Medical Corporation20139—
+4K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+4K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd.20212—
+4K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K161864ARIX Foot SystemJeil Medical Corporation20165—
+5K252251Easymade-TICG Bio Co., Ltd.20260—
+5K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.20260—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—