East Hartford, CT – [March 2025] – icotec is proud to announce that it has received FDA 510(k) clearance for the use of an Axial and Parallel Connectors on its VADER® Pedicle Systems.
This clearance marks a significant milestone for icotec, as it continues to innovate and provide advanced solutions for spinal stabilization. The extended VADER® Pedicle System maintains its proven indication and versatility for open, MIS and cement-augmented surgical techniques while providing additional options for stabilizing patients with spinal tumors and infections.
The VADER® Pedicle System now enables the transition from 6.0 mm to 6.0 mm rods with either BlackArmor® Carbon/PEEK or titanium rods. The Parallel Connector has two integrated radial joints, made of titanium alloy to facilitate rod insertion by 30° – this will allow maximum flexibility for the surgeon.
The Axial and Parallel Connectors offer several clinical benefits, including improved biomechanical stability and enhanced adaptability to various anatomical conditions. These connectors are designed to provide robust stabilization while allowing for improved postoperative imaging.
BlackArmor® Carbon/PEEK implants provide stabilization of the spine while being completely radiolucent, allowing for clear visualization in postoperative imaging, improved radiation planning and dose delivery, and expanding treatment options for patients with spinal tumors. icotec remains committed to advancing spinal care and providing innovative solutions that meet the needs of patients and healthcare providers.
About icotec ag
icotec is the leading company for the treatment of spinal tumors and spinal infections with a new generation of high-tech implants. With its BlackArmor® Carbon/PEEK implants, icotec combines cutting-edge technologies and industry expertise to deliver innovative and reliable solutions for spine surgeons and their patients and is dedicated to advancing the field of spinal implantation. With a track record of clinical success and a commitment to continuous innovation, icotec is poised to shape the future of spinal surgery. The comprehensive product portfolio has received FDA clearance and is supported by numerous Key Opinion Leaders and Cancer Therapy Centers worldwide. More information can be found at www.icotec-medical.com.
Contact
For more information or questions regarding this product update, please contact John Clough, Vice President of Global Product Management and New Indications:
john.clough@icotec-medical.com