510(k) Report

Devices descending from K213667

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+2K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+2K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+2K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+2K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+2K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+3K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—