Stryker receives FDA 510(k) clearance for Sahara Lateral 3D interbody system

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Stryker Sahara
Stryker has received US FDA clearance for the Sahara Lateral 3D expandable interbody system

Stryker has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Sahara Lateral 3D expandable interbody system. The product will be on display at the Society for Minimally Invasive Spine Surgery Annual Forum (SMISS; 31 Oct–2 November Las Vegas, USA).

Sahara is a 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. Utilising 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, Stryker said in a press release.

“Surgeons performing lateral spinal fusion often require versatility to help them achieve optimal outcomes for their patients,” said Gregory Poulter, orthopaedic surgeon at OrthoIndy in Indianapolis, USA. “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 to manufacture using traditional 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.

Eric Major, president of Stryker‘s Spine Division, said: “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 manoeuvres, all while reinforcing our commitment to excellence in medical innovation and improving quality of life for people with spinal deformities.”


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