Altus Spine Gains 510(k) for Monaco HA Pedicle Screw

By Julie A. Vetalice

Altus Spine Gains 510(k) for Monaco HA Pedicle Screw

Altus Spine received FDA 510(k) clearance to market the Monaco HA Pedicle Screw System.

Monaco HA comprises a low-profile construct and insertion devices, and features a hydroxyapatite (HA) coating over the entire thread length intended to enhance the fixation between the pedicle screw and surrounding bone.

Featuring many of the same qualities as the Monaco Pedicle Screw System, Monaco HA 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.

The HA Pedicle Screw is now indicated to provide immobilization and stabilization 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 Altus Spine HA Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma,  spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion in skeletally mature patients.

Source: Altus Spine

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory