510(k) Report

Devices descending from K203138

25 later devices reach FIREBIRD SI Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+1K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+1K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+1K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+2K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+2K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+2K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+2K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+3K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+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—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+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—