Sam Brusco, Associate Editor05.28.24
Spineart has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its SCARLET AC-Ti secured anterior cervical cage.
SCARLET AC-Ti introduces the feature of the MIMETIX morphometric profile, which was built with digital vertebrae models to optimize the contact surface between the implant and endplates. The system can achieve fixation with screws and anchors.
The cervical cage leverages Spineart’s prioprietary Ti-LIFE technology, a proprietary additive manufacturing process. This creates a porous structure that mimics the trabecular bone structure.
Ti-LIFE structure touts an average pore diameter of 0.9 mm, with overall porosity between 70% and 75% to enable cell colonization. Comparably, natural bone has about 70% to 95% porosity, with pore diameter ranging from 0.3 mm to 1.5 mm.
The SCARLET AC-Ti build on a decade of experience with the SCARLET system.
"This approval underscores our commitment to innovation, continuously evolving our most successful products, such as the SCARLET system," said Alessia Erlingher, chief commercial officer at Spineart.
In March 2024, the company announced it had completed enrollment in its U.S. investigational device exemption (IDE) trial evaluating its Baguera C cervical disc prosthesis for single-level cervical disease between C3 and C7. The trial will compare treatment with Baguera C to a commercially marketed cervical disc implant.
SCARLET AC-Ti introduces the feature of the MIMETIX morphometric profile, which was built with digital vertebrae models to optimize the contact surface between the implant and endplates. The system can achieve fixation with screws and anchors.
The cervical cage leverages Spineart’s prioprietary Ti-LIFE technology, a proprietary additive manufacturing process. This creates a porous structure that mimics the trabecular bone structure.
Ti-LIFE structure touts an average pore diameter of 0.9 mm, with overall porosity between 70% and 75% to enable cell colonization. Comparably, natural bone has about 70% to 95% porosity, with pore diameter ranging from 0.3 mm to 1.5 mm.
The SCARLET AC-Ti build on a decade of experience with the SCARLET system.
"This approval underscores our commitment to innovation, continuously evolving our most successful products, such as the SCARLET system," said Alessia Erlingher, chief commercial officer at Spineart.
In March 2024, the company announced it had completed enrollment in its U.S. investigational device exemption (IDE) trial evaluating its Baguera C cervical disc prosthesis for single-level cervical disease between C3 and C7. The trial will compare treatment with Baguera C to a commercially marketed cervical disc implant.