510(k) Report

Devices descending from K231689

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+2K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—