Stryker receives FDA clearance for SAHARA® Lateral 3D
19 November 2019
Stryker announced recently the U.S. Food and Drug Administration (FDA) 510(k) clearance of its SAHARA Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology, which will be on display at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum in Las Vegas, NV.
SAHARA Lateral is the first-ever 3D-printed lateral expandable fusion device and features passive expansion capabilities that are designed to allow surgeons to achieve up to 30 degrees of sagittal spinal correction in skeletally mature patients.
Utilizing a passive expansion mechanism, the implant can either be adjusted from a lateral approach intraoperatively or can adjust passively in a staged posterior approach following osteotomy.
SAHARA Lateral features Lamellar 3D Titanium Technology, which uses an advanced 3D printing method to create structures that were previously difficult or impossible to manufacture using traditional manufacturing techniques. Starting with a titanium powder, the SAHARA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a roughened surface architecture.