Spineart SA - FDA 510(k) Cleared Devices

Spineart SA, is a Swiss-based orthopedic medical device company founded in 2005. Headquartered in Geneva with a manufacturing facility in Plan-Les-Ouates, Switzerland, the company specializes in innovative spine surgery solutions. Their portfolio includes motion preservation technologies, posterior fixation systems, interbody fusion devices, and enabling surgical technologies.

Spineart has received 11 FDA 510(k) clearances from 11 total submissions since 2019. The company focuses exclusively on orthopedic devices, with a strong emphasis on minimally invasive spine surgery instrumentation and implants. Recent cleared devices include posterior thoraco-lumbar fixation systems, lumbar interbody devices, navigation instrument systems, and motion preservation implants. The company remains actively engaged in FDA regulatory submissions, with its latest clearance in 2026.

Spineart's product philosophy centers on quality, innovation, and simplicity. The company emphasizes streamlined surgical workflows, individually packaged and barcoded implants for full traceability, and patented technologies such as Ti-LIFE, a titanium porous structure designed to promote bone ingrowth. Their cervical disc prosthesis, launched in 2008, established the company as an innovator in motion preservation alternatives to spinal fusion.

Explore the complete list of Spineart's FDA 510(k) cleared devices, including product names, device codes, and clearance dates in the database.