Receive our newsletter – data, insights and analysis delivered to you
  1. News
May 10, 2017

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

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.”

Content from our partners
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU