Life Spine receives FDA 510(k) clearance for Cranial Fusion system

10 May 2017 (Last Updated May 10th, 2017 18:30)

Life Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its Cranial Fusion system with Solistice polyaxial screws in cervical spine indications.

Life Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its Cranial Fusion system with Solistice polyaxial screws in cervical spine indications.

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

Solistice polyaxial screws are available in diameters of 3.5mm to 4.5mm.

The screws feature a conical polyaxial head angulation that allows easy rod placement with less contouring. It also has a friction head, which maintains screw position within the surgical wound.

Life Spine marketing vice-president Mariusz Knap said: “With the clearance of the Cranial Fusion system, this is an opportunity to use our Solstice system screws for posterior cervical fusions.

"We continue to focus on advancements that strive to improve surgical efficiencies, ease of use and reliability of posterior occipito-cervico-thoracic fixation of the spine, providing the highest value of care to our customers and patients."

“We continue to focus on advancements that strive to improve surgical efficiencies, ease of use and reliability of posterior occipito-cervico-thoracic fixation of the spine, providing the highest value of care to our customers and patients.”

By using the 3.5mm/5.5mm titanium parallel connectors, the Cranial system can also be connected to the Nautilus Thoracolumbar Pedicle screw system for enhanced fixation

Designed to address various thoracic and lumbar spine pathologies, Nautilus system comes with a double helical screw thread for quick insertion.

The Cranial Fusion system’s hooks and rods provide further stabilisation for promoting fusion after the decrease in fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.