510(k) Report

Devices descending from K210667

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+1K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+2K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+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—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+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—