510(k) Report

Devices descending from K171595

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+1K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+1K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+1K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+1K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+2K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+2K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+2K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+2K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+2K203671M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.20212—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+3K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+3K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+3K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+3K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—