US FDA clears Life Spine’s Cranial Fusion system

100

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Life Spine for its Cranial Fusion system. This clearance expands the indications for utilising the company’s Solstice polyaxial screws into the cervical spine.

The Cranial Fusion system is a multiple component system comprised of titanium alloy, with a variety of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

Solstice polyaxial screws used with the system come in 3.5, 4 and 4.5mm diameters. The conical polyaxial head angulation is designed to facilitate easy rod placement with minimal contouring, and the “friction head” feature is intended to maintain screw head position within the surgical wound.

The Cranial Fusion system may also be connected to the Nautilus thoracolumbar pedicle screw system using the 3.5mm/5.5mm titanium parallel connectors. 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.

LEAVE A REPLY