FDA grants K2M 510(k) clearance for 3-D-printed corpectomy cage

K2M Group Holdings Inc. has announced it received FDA 510(k) clearance for the CAPRI Small 3D Static Corpectomy Cage System, which is first-to-market and the first system of this type to gain FDA clearance, according to a company press release.

The CAPRI system is also reportedly the third K2M device to use the company’s Lamellar 3-D Titanium Technology.

The CAPRI Small 3D Static System stabilizes the thoracolumbar spine. Its porous structure and rough surface allow for bony integration into the implant. Furthermore, sagittal balance may be achieved with the system’s lordotic options.

“K2M’s excellence in 3-D printing innovations allows us to aid surgeons in treating spinal pathologies across [minimally invasive surgery] MIS, degenerative, and now complex spine segments,” Eric Major, K2M president and chief executive officer, said in the release. “Today, we are excited to introduce CAPRI Small 3-D Static, a 3-D 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,” he said.

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