SI-BONE, INC. SI-BONE, Inc. confirmed that certain CD Horizon® Solera® 5.5mm and 6.0mm posterior spinal fixation rods manufactured by Medtronic Sofamor Danek USA Inc., a division of Medtronic plc, meet SI-BONE?s criteria for compatibility with iFuse Bedrock Granite® indicated in the Granite implant?s instructions for use. A complete list of Medtronic Solera® rods meeting the criteria for compatibility described in Granite?s cleared labeling is available on SI-BONE?s website. The iFuse Bedrock Granite implant was cleared by FDA on May 26, 2022.
FDA recognized the Granite implant?s significant advantages over existing approved or cleared alternatives in designating the product as a Breakthrough Device. CMS subsequently adopted a New Technology Add-on Payment of up to $9,828 per procedure, based on the individual hospital?s costs, for procedures reimbursed under the Medicare program and incorporating this new technology.
