K2M Cage, Bands and Connectors Cleared by FDA

K2M Group Holdings, Inc. sandwiched two FDA 510(k) Clearances around the Fourth of July. One for a 3D printed corpectomy cage and, the other, for a spinal proximal fixation system.

On June 28, 2017, the company announced the clearance of the Capri Small 3D Static Corpectomy Cage System. Calling the clearance, a milestone for the company, the system is a first-to-market 3D-printed cleared corpectomy cage. It is also the company’s third product group to feature Lamellar 3D Titanium Technology.

The system, according to the company, 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.

Michael Finn, M.D., a neurosurgeon and assistant professor in the University of Colorado Department of Neurosurgery, said 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.

The company says its 3D printing technology creates structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the 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.”

Nile Proximal Fixation Spinal System

The second FDA 510(k) Clearance, and CE Mark, was announced on July 6, 2017 for the company’s Nile Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation.

The fixation system consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for the fixation system also includes the use of anchors, which are not cleared for use in the U.S.

The bands are manufactured from polyethylene terephthalate and can be used to provide additional fixation in a MESA, MESA 2, EVEREST, or DENALI Spinal System construct through sublaminar passage or attachment to an anchor (OUS only). The band can then be integrated into the construct using the Nile transverse or medial offset connectors.

Greg Mundis, M.D., a surgeon specializing in pediatric and adult spinal deformity surgery in the Department of Orthopedics at Scripps Clinic Medical Group in La Jolla, California, says he has used many band technologies for proximal construct augmentation from different companies and the Nile system, “is a huge leap forward in simplifying the design to achieve this goal. K2M has made it elegant and efficient to place the connectors and tension the bands in a predictable fashion.”

John Ferguson, M.D., an orthopedic spine surgeon in Auckland, New Zealand, said the implants are straightforward and easy to use. “I think this product will be a very useful addition to many of my complex procedures.”

“This regulatory milestone—coupled with the recent launch of our Balance ACS (BACS) platform—further emphasizes our focus on achieving three-dimensional spinal balance, and ultimately Total Body Balance, for patients,” said the K2M’s President and CEO Eric Major.

Major added that BACS focuses on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing total body balance as an important component of surgical success.