510(k) Report

Devices descending from K180818

30 later devices reach Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+1K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+1K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+1K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+1K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+1K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+1K213815SiJoin®T3Vgi Medical, Inc.20230—
+1K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+1K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+1K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+1K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+2K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+2K241895Cannulated PsiFGuardSpineguard20240—
+2K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+2K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+2K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+2K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+2K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+2K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+3K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+3K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+3K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+3K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+3K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+3K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+4K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—