510(k) Report

Devices descending from K222605

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+1K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+1K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+1K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+1K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+2K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+2K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+2K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—