icotec ag's VADER® Pedicle System Navigated Instruments Gain FDA 510(k) Clearance for Safer Spinal Implantation

28th July, 2023

icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This achievement represents a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants.

VADER Pedicle System Navigated Instruments

As part of our commitment to providing the safest and most seamless surgical experience, icotec has integrated assistive technologies, such as navigation, into our instrumentation. This combination of standard surgical techniques with advanced navigation capabilities ensures that our procedures align with industry standards and deliver optimal outcomes for our patients.

The newly cleared Navigation set includes a comprehensive range of instruments, for both Open and MIS surgery. This expanded portfolio empowers surgeons with enhanced precision and accuracy during procedures, enabling them to achieve superior outcomes for their patients.

"Receiving FDA 510(k) clearance for our navigated instrumentation is a significant achievement for icotec," said Roger Stadler, CEO at icotec, "We are proud to offer our surgeons the tools they need to perform these procedures with the utmost precision and confidence. This clearance opens new opportunities for growth and reaffirms our position as the leader in Carbon/PEEK implants and our commitment to keeping a standard surgical technique."

icotec would like to extend its gratitude to the entire team for their dedication and hard work in making this successful upcoming launch possible. Their commitment to innovation and patient-centered care has been instrumental in achieving this milestone.