Altus Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of its Monaco HA pedicle screw system.
The Monaco HA pedicle screw system, consisting of a low-profile construct and insertion devices, features a new optimised surface intended for enhanced fixation. The Monaco HA screws have a hydroxyapatite (HA) coating over the entire thread length, largely consisting of calcium and phosphorus, which is intended to enhance the fixation between the pedicle screw and the surrounding bone.
Michael Fitzgerald, president and CEO of Altus Spine, said: “To optimise fixation, our team is utilising a HA coating over the screw thread—a game changer when it comes to thread purchase and pull-out strength.”
Monaco HA also includes a friction fit screw head so it remains in the appropriate position for rod implantation and a small outer diameter for optimal bone graft placement, say Altus Spine.
The FDA clearance means that the HA pedicle screw system is now indicated to provide immobilisation and stabilisation of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The system is intended for non-cervical pedicle fixation for the following indications: Degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumour; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
“This FDA clearance is a huge step in expanding our dynamic and innovative solutions to provide immobilisation and stabilisation in the thoracic, lumbar, and sacral spine,” added Fitzgerald. “Our goal is to continue advancing and creating top of the line, world-class products with the latest technologies to provide better outcomes for our patients.”