Altus Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of its Sochi OCT system—which is comprised of polyaxial screws, hooks, rods, locking screw assemblies and connectors which can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.
“To adapt to a wide variety of patient anatomies, while also accommodating surgeon preference, our team designed a system that can be configured in multiple different variations.” said Michael Fitzgerald, president and CEO of Altus Spine.
The FDA’s action means that the Sochi OCT system is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput–T3). According to Altus Spine, the intended indications are: degenerative disc disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, deformities or curvature, tumours, pseudarthrosis, atlanto/axial fracture with instability, occipitocervical dislocation, and revision of previous cervical and upper thoracic spine surgery.
The hooks and rods are also intended to provide stabilisation to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1–T3) spine. The system can also be linked to the company’s Monaco pedicle screw system with the use of transition rods and rod connectors.
“This FDA clearance is a great addition to our diverse portfolio of products. Its ability to configure and adjust to a wide variety of patients is a design aspect that is very beneficial in the field,” added Fitzgerald. “As we continue advancing our portfolio by creating innovative products and technologies, our leading goal is providing better outcomes for our patients while solving complications surgeons face in the operating room.”