510(k) Report

Devices descending from K220195

32 later devices reach iFuse Bedrock Granite™ Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+1K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+1K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+1K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+1K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+1K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+2K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+2K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+2K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+2K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+2K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K252322SIros-X SystemGenesys Spine20250—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—