f1709a2a-7e9a-4fe8-a578-fe104e62c001NewPublished12026-02-022026-01-23In Commercial DistributionM719GSIXFR0950600PrimaryHIBCCSIros-X1GSI-XFR095060017921066Genesys Orthopedics Systems LLC19.5mm x 60mm SIros-X FA Reduction ScrewfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse5123817070info@genesysspine.comK25232200046651Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.trueActive61485Sacroiliac joint transarticular fixation/arthrodesis implant, uncoatedAn implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.trueActiveOURSacroiliac Joint FixationOLOOrthopedic Stereotaxic InstrumentNKBThoracolumbosacral Pedicle Screw SystemOuter DiameterLengthfalsetrueMoist Heat or Steam Sterilization