Stryker (NYSE:SYK) said yesterday that it won FDA 510(k) clearance for its Sahara lateral 3D expandable interbody implant system.
Sahara Lateral is the first ever 3D-printed lateral expandable fusion device, according to a news release. It is designed to allow surgeons up to 30 degrees of sagittal spinal correction in skeletally mature patients. The implant is adjustable from a lateral approach intra-operatively, or can adjust passively in a staged posterior approach after osteotomy.
Stryker’s device includes Lamellar 3D titanium technology, which is designed to use a 3D printing method in creating structures that previously couldn’t be manufactured using traditional techniques. Sahara implants are grown through application of a high-energy laser beam and the roughened titanium surfaces have shown increased protein expression when compared to smooth titanium surfaces.
The company said the Sahara Lateral complements the Sahara anterior lumbar expandable stabilization system, a lordotic expandable device with integrated screw fixation. The Sahara Lateral is designed to match a patient’s anatomy in use with supplemental fixation systems cleared for use in the lumbar spine.
“At Stryker, inventing state-of-the-art solutions that address unmet clinical needs is essential to our vision and purpose,” spine president Eric Major said in prepared remarks. “Sahara Lateral, which will be on display at this year’s SMISS annual forum, provides surgeons and hospital systems with a 3D-printed solution for complex posterior correction maneuvers, all while reinforcing our commitment to excellence in medical innovation and improving quality of life for people with spinal deformities.”
“Surgeons performing lateral spinal fusion often require versatility to help them achieve optimal outcomes for their patients,” added OrthoIndy (Indianapolis) orthopedic surgeon Gregory Poulter. “Stryker’s Sahara Lateral, with its expansion mechanism that is both actively adjustable from a lateral approach and passively adjustable during a staged posterior procedure, provides an excellent 3D-printed option to help these patients.”
Shares of SYK were up 0.3% at $216.88 per share in midday trading today.