510(k) Report

Devices descending from K100776

228 later devices reach Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—