510(k) Report

Devices descending from K030302

12 later devices reach HBS Headless Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH20180—
+1K112672Headless Compression ScrewSkeletal Dynamics, LLC201110—
+2K143624Headless Compression Screw SystemSkeletal Dynamics, LLC20157—
+2K132910Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC20134—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K201662REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc.20202—
+3K192744CORRIDOR Fixation SystemGlobus Medical, Inc.20192—
+3K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc.20143—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc.20221—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K230908Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc.20230—