510(k) Report

Devices descending from K150017

14 later devices reach SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+1K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+1K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+1K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+2K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+2K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+2K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+2K231831TiLink-L Joint Fusion SystemSurgentec20232—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—