510(k) Report

Devices descending from K241574

4 later devices reach iFuse TORQ® Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+1K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+1K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+2K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—