510(k) Report

Devices descending from K190230

57 later devices reach iFuse Implant System® through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+1K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+1K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+2K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+2K251365OptumSI Implant SystemSi Solutions, LLC20250—
+2K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+2K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+2K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+2K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+2K230817TORPEDO Implant System®Deltacor GmbH20240—
+2K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+2K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+2K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+2K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+2K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+2K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+3K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+3K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252322SIros-X SystemGenesys Spine20250—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—