SurGenTec announced today that it received FDA 510(k) clearance for its 3D GraftRasp system for orthopedic use and spine procedures.
Boca Raton, Fla.-based SurGenTec’s 3D GraftRasp system is designed for both the decortication of bone and the delivery of autograft, allograft or synthetic bone graft, according to a news release. The company touts it as ideal for use in posterolateral or intertransverse lumbar fusion cases, as it allows physicians to access the anatomy while making less invasive incisions and offering the same standard of care as with an open lumbar fusion.
The system includes straight or curved rasps, specific to the surgical site anatomy. The rasps feature disposable footplates with conical teeth for ensuring optimal decortication.
3D GraftRasp can be used in conjunction with the GraftGun delivery system for facilitating controlled bone graft delivery to the surgical site, as the graft is extruded with accuracy through an aperture in the rasp directly to the decorticated area.
“FDA clearance of the 3D GraftRasp system expands our treatment modalities in the spine market. This is an exciting time for our company and for physicians who need intuitive instruments to treat their patients,” SurGenTec COO Andrew Shoup said in the release. “Physicians want efficiency and better outcomes, while patients want a better chance to resume a lifestyle that makes them happy and pain-free.”