510(k) Report

Devices descending from K040907

249 later devices reach Arthrex Small Fragment Plates and Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+6K254280F.A.S.T ScrewSteps Ortho20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—