Medical technology firm Stryker has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Sahara lateral 3D expandable interbody system.
Sahara Lateral 3D expandable interbody system, which features Lamellar 3D Titanium technology, is claimed to be the first ever 3D-printed lateral expandable fusion device.
Lamellar 3D Titanium technology helps to apply an advanced 3D printing method to create structures, which were earlier difficult to produce using traditional manufacturing techniques.
The device includes passive expansion capabilities that will help surgeons to achieve up to 30 degrees of sagittal spinal correction in skeletally mature patients.
With 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 Lateral3D expandable interbody system is available in a variety of footprints
The company is providing the Sahar Lateral in a variety of footprints, heights and lordotic offerings to accurately match patient’s anatomy. It is also designed to be used with supplemental fixation systems approved for use in the lumbar spine.
Sahara Lateral is said to compliment the Sahara anterior lumbar expandable stabilisation system, a lordotic expandable device with integrated screw fixation.
According to the company, the Sahara implants are grown through the selective application of a high-energy laser beam, integrating complex internal geometries and a roughened surface architecture.
Roughened titanium surfaces have been shown to demonstrate increased protein expression, which many not happen with smooth titanium surfaces.
The company will showcase the Sahara lateral 3D expandable interbody system at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum this week in Las Vegas, US.
Stryker spine division president Eric Major said: “At Stryker, inventing state-of-the-art solutions that address unmet clinical needs is essential to our vision and purpose.
“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.”
