510(k) Report

Devices descending from K221047

9 later devices reach SILO TFX MIS Sacroiliac Joint Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241895Cannulated PsiFGuardSpineguard20240—
+1K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+1K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+2K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+2K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+3K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+4K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—