510(k) Report

Devices descending from K222774

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+1K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+1K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+1K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+1K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+1K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+2K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+2K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K252322SIros-X SystemGenesys Spine20250—
+2K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+2K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—