RTI Surgical has introduced a 3D-printed device for treating degenerative disc disease. The implant has roughened surfaces designed to enable human cells—but not bacteria—to attach and improve bone formation.
Evidence to support that hypothesis comes from animal and in vitro studies. RTI will need clinical outcomes data to fully make the case that the Fortilink-C interbody fusion device marks a leap forward from existing implants, such as its own polyetheretherketone (PEEK) C-Plus system. But it has already done enough to bag FDA clearance for the device and convince early adopters of its value.
“The Fortilink-C system has ushered in a new beginning for cervical fusion cages. We have gone from iliac crest to cadaver bone to PEEK and titanium, and now, Fortilink-C IBF System,” Richard Nussbaum, M.D., an orthopaedic surgeon, said in a statement. “The enhanced implant design increases the surface area and, in an animal model, shows greater circumferential bony ingrowth.”
Nussbaum was the first surgeon to implant the device, which uses RTI’s TETRAfuse 3D Technology. TETRAfuse builds up the device layer by layer, resulting in devices RTI thinks cut the likelihood of subsidence while retaining their strength. The production technique also creates macro and micro structures on the surface of the device, giving cells more points to latch onto and initiate bone growth.
RTI thinks Fortilink-C is the first device to feature such nooks and crannies across its entire surface. Earlier products have incorporated these features into their endplates.
The introduction of the device comes five months after the FDA cleared (PDF) it for sale under its 510(k) approval pathway. The agency reached the decision after comparing the device to those already sold by RTI.
RTI presented data from static and dynamic axial compression and torsion tests, static subsidence assessments and static expulsion evaluations to make its case for the approval of the latest product in its fusion device portfolio. The FDA concluded the mechanical strength of the fusion device is equivalent to that of its predecessors.
That decision teed RTI up to start marketing Fortilink-C for use in skeletally mature patients with degenerative disc disease. Implantation of the device is intended to enable interbody fusion in the cervical spine.