510(k) Report

Devices descending from K121148

35 later devices reach Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+1K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+1K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+1K173752SI Screw SystemZavation Medical Products, LLC20180—
+2K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+2K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+3K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+3K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—