510(k) Report

Devices descending from K172268

46 later devices reach iFuse Implant System- iFuse Navigation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+1K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+1K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+1K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+1K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+2K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+2K252322SIros-X SystemGenesys Spine20250—
+2K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+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—
+2K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+2K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+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—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+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—