510(k) Report

Devices descending from K043185

405 later devices reach Synthes 3.5MM Cortex Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+1K222505CurvaFix IM SystemCurvafix, Inc.20221—
+1K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K180050CurvaFix Intramedullary Rodscrew SystemCurvafix, Inc.20193—
+1K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+1K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+1K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160—
+1K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+1K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd.20139—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+1K111230Synthes 3.5MM Low Profile Cortical ScrewSynthes (USA) Products, LLC2011122—
+1K103705Low Profile ScrewsArthrex, Inc.2011219—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+1K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+1K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080—
+1K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+1K062494Ebi Optilock Upper Extremity Plating SystemEbi, L.P.2006221
+1K061607Storm Operating Kit, Model 1-10-0Intelligent Orthopaedics, Ltd.20061—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+2K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+2K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+2K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+2K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+2K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221088Anatomic Bone PlateDouble Medical Technology, Inc.20231—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+2K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+2K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+2K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.20200—
+2K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+2K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+2K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+2K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+2K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+2K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+2K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+2K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+2K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+2K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+2K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+2K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+2K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+2K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+2K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+2K110201Explor Radial Head Plating SystemBiomet, Inc.20110—
+2K110320Comprehensiveproximal Humeral Plating SystemBiomet Manufacturing Corp20110—
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K111001Sterile Storm (R) Operating KitIntelligent Orthopaedics, Ltd.20110—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—