K2M Group Holdings, Inc. announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case. CAPRI Cervical 3D Expandable is the world’s first and only 3D-printed expandable device on the market to facilitate continuous in-situ height expansion and endplate angulation in the cervical spine.
The CAPRI Cervical 3D Expandable Cage System stabilizes the cervical spine in cases of vertebral body resections resulting from trauma or tumor. Offered in various footprint options, its continuous in-situ adjustment capabilities allow surgeons to lock the cage with set screws at desired heights and lordotic angles within the expansion range of the implant. The system also allows for fixed endplate angulation of 0°, 5°, and 10° to accommodate surgeon preference and vertebral anatomy.
“Never before has a cervical corpectomy cage combined the capabilities of 3D printing with the functionality of continuous in-situ height and lordotic adjustment,” said Lars Valentin, MD, of Rigshospitalet in Denmark. “Using the CAPRI Cervical 3D Expandable Corpectomy Cage,” explained Martin Gehrchen, MD, PhD, chief of spine surgery at Rigshospitalet in Denmark, “we were able to dial in a precise height and lordotic angle in-situ while also utilizing a 3D-printed device designed to allow for bony integration.”
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 Cervical 3D Expandable 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 Chairman, President, and CEO Eric Major said, “We are pleased to receive a CE Mark for our CAPRI Cervical 3D Expandable Cage System, which reinforces our commitment to excellence in 3D-printed spinal innovation and the further integration of expandable technologies across our comprehensive complex spine, minimally invasive, and degenerative product portfolios. We look forward to further strengthening our market-leading portfolio of 3D-printed spinal devices that, when supported by our comprehensive Balance ACS platform, help surgeons facilitate three-dimensional spinal balance in their patients.”
This product is intended for export and is not sold or offered for sale in the United States.