510(k) Report

Devices descending from K160652

83 later devices reach iFUSE Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+2K182983iFuse Implant System®SI-BONE, Inc.201871—
+2K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+3K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+3K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+3K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+3K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K190230iFuse Implant System®SI-BONE, Inc.201957—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+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—
+4K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+4K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+5K251365OptumSI Implant SystemSi Solutions, LLC20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+5K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K230817TORPEDO Implant System®Deltacor GmbH20240—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+5K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+5K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+6K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+6K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+7K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—