K2M announced that its CAPRI™ Small 3D Static Corpectomy Cage System has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). CAPRI Small 3D Static is a first-to-market, 3D-printed, FDA-cleared corpectomy cage, and the Company's third product family to feature Lamellar 3D Titanium Technology™. This clearance marks a milestone for the Company, which provides 3D-printed solutions for MIS, degenerative, and now complex spine procedures. K2M was the first leading spine company to market a 3D-printed spinal implant and offers the most comprehensive portfolio of 3D-printed spinal devices.
CAPRI Small 3D Static provides a surgical solution for stabilizing the thoracolumbar spine (T1 to L5) in cases of vertebral body resections resulting from trauma or tumor. Its porous structure and rough surface architectures are designed to allow for bony integration throughout an implant. The system's lordotic options help support the anterior spinal column with the goal of achieving sagittal balance.
"CAPRI Small 3D Static provides me with a corpectomy cage that incorporates the Lamellar 3D Titanium Technology to treat patients with complex pathologies," said Michael Finn, MD, a neurosurgeon and assistant professor in the Department of Neurosurgery at the University of Colorado. "The incorporation of pores into the endplates increases the surface area for fusion and presents the potential for bone to grow into the corpectomy cage."
K2M's Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CAPRI Small 3D Static corpectomy cages are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the cage.
"K2M's excellence in 3D-printing innovations allows us to aid surgeons in treating spinal pathologies across MIS, degenerative, and now complex spine segments," said K2M's President and CEO Eric Major. "Today, we are excited to introduce CAPRI Small 3D Static, a 3D-printed surgical solution for correcting complications from trauma or tumor in complex spine cases. This is our third product family—which already includes the CASCADIA™ 3D family of static interbodies and the MOJAVE™ PL 3D Expandable Interbody—to feature Lamellar 3D Titanium Technology.