510(k) Report

Devices descending from K193083

21 later devices reach M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+1K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+2K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+2K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+3K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+3K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+3K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—