510(k) Report

Devices descending from K170518

15 later devices reach In2Bones Fracture and Correction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+1K201149CoLink Plating SystemIn2bones USA, LLC20200—
+1K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+1K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+1K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+1K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+2K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—