FDA Clears SAHARA Lateral 3D Expandable Interbody System From Stryker

The U.S. Food and Drug Administration (FDA) has granted Stryker Corp. 510(k) clearance of its SAHARA Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.
 
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.
 
“Surgeons performing lateral spinal fusion often require versatility to help them achieve optimal outcomes for their patients,” said Gregory Poulter, orthopedic surgeon at OrthoIndy in Indianapolis. “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.”
 
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. Roughened titanium surfaces have been shown to demonstrate increased protein expression in contrast to smooth titanium surfaces.^1-3
 
“At Stryker, inventing solutions that address unmet clinical needs is essential to our vision and purpose,” said Eric Major, president of Stryker’s Spine Division. “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.”
 
SAHARA Lateral complements the SAHARA Anterior Lumbar Expandable Stabilization System, a lordotic expandable device with integrated screw fixation. SAHARA Lateral is available in a variety of footprints, heights and lordotic offerings designed to more precisely match a patient’s anatomy and is intended to be used with supplemental fixation systems cleared for use in the lumbar spine.
 
Stryker’s Spine Division is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. The spine business unit offers a comprehensive and diverse product portfolio, including 3D-printed technologies, enabling surgeons to provide their patients with treatment options. Stryker’s products include implants, instruments, and biologic solutions for the cervical, thoracic and lumbar spine.
 
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers products and services in Orthopedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
 
References:
¹ Olivares-Navarrete R, Hyzy SL, Slosar PJ, Schneider JM, Schwartz Z, and Boyan BD. Implant materials generate different peri-implant inflammatory factors. Spine 40 (2015): 399-404.
² Olivares-Navarrete R, Gittens RA, Schneider JM, Hyzy SL, Haithcock DA, Ullrich PF, Schwartz Z, and Boyan BD. Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic protein production on titanium alloy substrates than on poly-ether-ether-ketone. The Spine Journal 12 (2012): 265-272.
³ Lincks J, Boyan BD, Blanchard CR, Lohmann CH, Liu Y, Cochran DL, Dean DD, and Schwartz Z. Response of MG63 osteoblast-like cells to titanium and titanium alloy is dependent on surface roughness and composition. Biomaterials 19 (1998): 2219-2232.