510(k) Report

Devices descending from K131920

18 later devices reach Stabilization Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254280F.A.S.T ScrewSteps Ortho20260—
+1K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+1K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+1K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+1K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+2K201149CoLink Plating SystemIn2bones USA, LLC20200—
+2K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+2K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+2K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+2K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—