510(k) Report

Devices descending from K091614

156 later devices reach Osteomed Foot Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+4K171510Footmotion Plating SystemNewclip Technics20171—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170012Foot and Hand MotionNewclip Technics20170—
+4K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+5K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K211843PolyLock Plating SystemFusion Orthopedics20220—
+5K213214Xpert WristNewclip Technics20210—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—