FDA clears metal additively manufactured spinal cage for market
July 12, 2017
The Capri Small 3D Static Corpectomy Cage System (Courtesy K2M)
The US Food & Drug Administration (FDA) has cleared a metal additively manufactured spinal cage for market. The CAPRI Small 3D Static Corpectomy Cage System produced by K2M, Virginia, USA, is reportedly the first metal additively manufactured corpectomy cage to receive FDA clearance, and is the company’s third medical product to feature Lamellar 3D Titanium Technology™.
The Corpectomy Cage is designed to provide a surgical solution for stabilising the thoracolumbar spine in cases of vertebral body resections resulting from traumatic spinal injury or tumour growth. The cage may also be used to stabilise the spine in cases of degenerative disease.
As with many titanium additively manufactured implants, the key benefit of the cage is its porous structure and rough surface architecture, which allows for bone ingrowth throughout the implant. The system’s lordotic options (enabling it to mimic the curvature of the patient’s lumbar and cervical spine) help to support the anterior spinal column for better balance.
“K2M’s excellence in 3D-printing innovations allows us to aid surgeons in treating spinal pathologies across MIS, degenerative, and now complex spine segments,” stated Eric Major, K2M’s President and CEO. “Today, we are excited to introduce CAPRI Small 3D Static, a 3D-printed surgical solution for correcting complications from trauma or tumour in complex spine cases.”
