510(k) Report

Devices descending from K193524

54 later devices reach SI-BONE iFuse Implant System® through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251365OptumSI Implant SystemSi Solutions, LLC20250—
+1K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+1K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+1K230817TORPEDO Implant System®Deltacor GmbH20240—
+1K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+1K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+1K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+1K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+1K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+2K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+2K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+2K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+2K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+2K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+2K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+2K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+2K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+2K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+3K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+3K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252322SIros-X SystemGenesys Spine20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—