510(k) Report

Devices descending from K231944

4 later devices reach CATAMARAN SI Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+1K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+1K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+2K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—