510(k) Report

Devices descending from K052614

245 later devices reach Low Profile Plate and Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+5K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—