SPINEART RECEIVES CLEARANCE FROM THE FDA TO MARKET ITS TI-LIFE TECHNOLOGY 3D TITANIUM INTERBODY DEVICES
Spineart is pleased to announce that it has received 510(k) clearance from the FDA to market its new JULIET®Ti lumbar interbody systems in the United States.
The JULIET®Ti PO, OL and TL interbody systems are the first range of titanium interbody implants benefiting from our proprietary Ti-LIFETechnology1.
Ti-LIFETechnology micro-porous scaffold mimics the bone trabecular structure and features interconnected pores of 600 μm to 700 μm and an overall porosity of 70-75% designed to enable cell colonization and promote bone in-growth2.
This technology is based on a unique algorithm associated with a state-of-the-art additive manufacturing process, often referred to as 3D printing.
The JULIET®Ti PO, OL and TL interbody systems include a full range of sizes to address different anatomies. The smooth bullet-shaped nose, lateral sides and chamfers of the implant are polished to preserve endplates, nerve roots and soft tissues during insertion.
The JULIET®Ti design features an overall reduced density to optimize imaging performance.
In accordance with the Spineart philosophy, the instrument set is ultra-compact and features multi-functional instruments.
All Spineart implants, including the entire JULIET®Ti range, are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency.
For distribution opportunities please contact us at contact@spineart.com or visit spineart.com/distributorsUSA.
1Filed patent
2Pre-clinical data may not represent clinical results.
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