510(k) Report

Devices descending from K151462

5 later devices reach SI-Technology® SI-Desis® Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+1K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+2K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+2K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—