Full-End Plate Cervical Cage Cleared by FDA
German medical device maker, NGMedical, Inc., has received its first FDA 510(k) clearance.
The January 28, 2021 clearance is for the company's 3-D printed titanium cervical BEE cage. The company says the cage's honeycomb structure allows for bony ingrowth and "demonstrates the reduced use of titanium minimizing risks of X-ray artifacts."
In a February 3, 2021 announcement, the company also claims, "another significant innovation from the team, who invented the first line of additive manufactured interbody devices." NGMedical evolved out of Advanced Medical Technologies AG, which was acquired by Medtronic Inc. in 2012.
The cages, according to the FDA clearance documents, are intended for intervertebral body fusion in skeletally mature patients “for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or two contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment.”
The documents also state that the tapered nose design "provides ease of insertion" while the convex superior and flat inferior surfaces "replicate the patient’s vertebral anatomical architecture for maximum surface contact."
The cage's cranial and caudal surfaces have a honeycomb geometry that accepts packing of bone graft to help facilitate bony integration. The device consists of implants available in two widths, one depth, seven heights, and three lordotic angles.
The cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
Lengthy FDA Scrutiny
The primary predicate device was another German cage, the EIT Cellular Titanium Cervical Cage from EIT Emerging Implant Technologies GmbH. It took the agency almost a full year to clear the device. Josh Sandberg, the company's U.S. representative told OTW the reason for the lengthy FDA review was due to the cage's full-end plate coverage design.
He added that the cage "addresses every key metric including anatomical design for bony fusion, maximum porosity with improved imaging and increased surface area minimizing subsidence.”