510(k) Report

Devices descending from K162171

3 later devices reach S4 Screw System™ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+1K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+2K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—